RESTRICTED  
  
G/TBT/M/88  
 
8 Februar y 2023  
(23-0945) Page: 1/127 
Committee on Technical Barriers to Trade    
 
  
MINUTES OF THE MEETING 16 -18 NOVEMBER 2022  
CHAIRPERSON: MR. ANWAR HUSSAIN SHAIK  
Note by the Secretariat1 
Contents  
1   ADOPTION OF THE AGENDA  ................................ ................................ ........................  1 
2   IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT  ................................ . 2 
2.1   Specific Trade Concerns  ................................ ................................ ...............................  2 
2.1.1    Withdrawn concerns  ................................ ................................ ................................ .. 2 
2.1.2   Reported progress on STCs  ................................ ................................ ........................  2 
2.1.3    New Specific Trade Concerns  ................................ ................................ ......................  3 
2.1.4    Previously raised concerns  ................................ ................................ ........................ 33 
2.2   Exchange of Experiences  ................................ ................................ ...........................  120 
2.2.1    Transparency  ................................ ................................ ................................ ........  120 
2.2.2    Tenth Special Meeting on Procedures for Information Exchange  ................................ ... 122 
2.2.3    Conformity Assessment Procedures  ................................ ................................ ..........  122 
2.2.4    Regulatory Cooperation between Members  ................................ ................................  122 
2.2.5    Covid -19 ................................ ................................ ................................ ..............  122 
2.2.6    Other Matters  ................................ ................................ ................................ ........  123 
3   TECHNICAL COOPERATION ACTIVITI ES ................................ ................................ .. 125  
4   OBSERVERS  ................................ ................................ ................................ .............  126  
4.1   Updates from Observers  ................................ ................................ ............................  126 
5   ANNUAL REPORT (2022) OF THE COMMITTEE TO THE COUNCIL FOR TRADE IN GOODS
 ................................ ................................ ................................ ................................ .... 127  
6   DATE OF NEXT MEETING ................................ ................................ ..........................  127  
 
 
 
1  ADOPTION OF THE AGENDA  
1.1.  The Committee  adopted the agenda contained in WTO/AIR/TBT/24 . 
 
1 This document has been prepared under the Secretariat's own responsibility  and is without prejudice 
to the positions of Members or to their rights and obligations under the WTO.  G/TBT/M/88  
 
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  2  IMPLEMENTATION  AND ADMINISTRATION OF THE AGREEMENT  
2.1  Specific Trade Concerns  
2.1.1   Withdrawn concerns  
2.1.  The Chair  reported that the following STCs had been withdrawn from the agenda at the request 
of the concerned Member:  
• European Union - Geographical indications for wine, spirit  drinks and agricultural 
products, and quality schemes for agricultural products  
• Thailand - Industrial Standard for Air -Conditioner: Safety Requirement (TIS 1529 -
2561(2018))  
• United States - Energy Conservation Program: Energy Conservation Standards for 
Variable Refrigerant Flow Multi -Split Air Conditioners and Heat Pumps  
• European Union - Regulations on plant protection products sprayed by drones in EU 
2009/128/EC and (EU) 2021/ 2115  
• European Union - Draft Commission delegated regulation ame nding regulation (EU) 
2019/2144 of the European Parliament and of the Council to take into account 
technical progress and regulatory developments concerning amendments to vehicle 
regulations adopted in the context of the United Nations Economic Commission for 
Europe. (ID 752)  
• Indonesia - Import quota and SNI certification requirements (ID 728)  
• India - Import Policy of Air Conditioners with Refrigerants (ID 748)  
2.1.2   Reported progress on STCs  
2.2.  The representative of the United States  provided an update on Banglades h's Hazardous Waste 
(E-waste) Management Rules, ID 620 , raised at the June 2022 Committee meeting. During July 's 
meeting, Bangladesh had provided a helpful  statement confirming that Bangladesh had revised its 
list of restricted substances under the Rules, in response to the request of the United States and 
other Members. Further, Bangladesh confirmed that the restricted substance provisions would  not 
come into effect until 2026, that registration under the e -waste provisions did not have a deadline, 
and that it would be developing detailed guidelines that would  help with implementation prior to 
then.  The US greatly appreciate d this update, which directly answered some of the questions they 
had posed under this STC.  Moreover, constructive communication betwe en Enquiry Points and 
Geneva mission representatives had resulted in Bangladesh notifying the E -waste Management rules 
as its third notification to the Committee in February of 2020. Communication continued with the 
full text being received in 2020, and a subsequent comment extension. The United States continued 
to have questions regarding the Rules which it was hoped could be discuss ed bilaterally with 
Bangladesh.   For example, the current draft rules did not provide exemptions for critical hazardous 
substances for products where no technically equivalent substitutes were available for critical uses 
such as protective uses of lead shielding in x -ray equipment.  It was also noted that developing an 
infrastru cture to ensure the appropriate handling of e -waste seem ed vital to the success of this 
measure.   The US looked forward to bilateral engagement on these points as Bangladesh further 
consider ed policy options, guidelines, and subsequent implementing measure s, and thank ed 
Bangladesh for its previous responses in the Committee.  G/TBT/M/88  
 
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  2.3.  The representative of the United States  went on to highlight a recent positive development and 
to thank Mexico for its collaboration to work to resolve the concerns raised by the United  States and 
U.S. industry stakeholders.   Mexico had notified a draft measure in September 2021 (in 
G/TBT/N/MEX/502) , which aimed to amend the requirements and specifications for safety devices 
for new light -duty vehicles. Following the notification, the United States and Mexico h eld several 
bilateral discussions on the margins of the TBT Committee meetings, and representatives from the 
US Embassy in Mexico City, participated in a working group convened by Mexico 's Ministry of 
Economy to review public comments submitted on the draf t. On 3 October 2022, Mexico published 
in the Official Gazette, the final version of Official Standard PROY -NOM-194-SE-2021.   While still 
reviewing the latest publication, and consulting industry, the US was pleased to express its 
appreciation and share its support for modifications made to the NOM in line with US comments, 
including adjusting the implementation date, continuing acceptance of manufacturers ' certification 
of compliance, and not making certain elements mandatory.  The US believe d that these bi lateral 
discussions, and its participation in the working group, helped lead to positive procedural 
developments, and showcase the importance of open dialogue and of meetings like these. The US 
again thanked Mexico for its willingness to engage on this top ic and look ed forward to engaging 
further on this issue.  
2.1.3   New Specific Trade Concerns  
2.1.3.1   European Union - Proposal for a regulation of the European Parliament and the 
Council on general product safety, amending Regulation (EU) 1025/2012 of the European 
Parliam ent and of the Council, and repealing Council Directive 87/357/EEC and Directive 
2001/95/EC of the European Parliament and of the Council (COM/2021/346 - final), 
G/TBT/N/EU/885  (ID 7622) 
2.4.  The representative of China  provided the following statement. China would like to thank the 
EU for the notification. China has made comments within the comment period and unfortunately has 
not yet received a reply. It is suggested, firstly the EU distinguish the compliance requirements for 
low-risk and high -risk products, and regularly adjust the cat alogue of low -risk and high -risk products 
to realize dynamic supervision; secondly, the EU provides a well -resourced and cost -effective RSP 
(responsible person for products)  system, ensuring that the manufacturer/importer can bear 
reasonable financial and administrative burdens of compliance. The EU could consider auditing and 
keep on record an EU RSP to make sure that the RSP can provide appropriate services and assume 
corresponding responsibilities. It is mentioned in this regulation that th e EU RSP shall conduct 
general sample tests on all products. If testing obligations need to be retained, it is advised for them 
to be limited to high -risk products based on specific data; and to EU RSPs who are themselves, 
manufacturers and importers. If n ecessary, it should be accepted that all other EU RSPs could 
provide a test report from an accredited laboratory on request, whether the test is commissioned by 
the manufacturer or someone else; and they are not responsible for physical testing, but only 
responsible for the documentation check of the product's compliance. Finally, it is suggested that 
the EU set up a three -year transition period and provide necessary regulatory interpretation in view 
of the broader scope and obligations of this system.  
2.5.  In response, the representative of the European Union  provided the following statement. The 
European Union would like to thank the Delegation of the People's Republic of China for its 
observations on the proposal for General Product Safety Regulation and their  written comments of 
6 July 2022. The reply of the written comments is under preparation. The General Product Safety 
Regulation proposal, if adopted as proposed by the Commission, would apply to products placed or 
made available on the European market in s o far as there are no specific provisions with the same 
objective in the Union law, which regulate the safety of the products concerned. In this sense, it 
would complement Regulation (EU) 2019/1020 on market surveillance ("Market Surveillance 
Regulation") as a safety net. The obligation to have a responsible person established in the European 
Union, as a condition to place products in the Union market, has been introduced for certain 
categories of harmonised products (e.g. toys, electric equipment, cosmetic  products, machinery, 
etc.) in the recently adopted Market Surveillance Regulation. This requirement is essential to 
facilitate market surveillance and help ensuring the safety of products entering the Union market 
from third countries. In this regard, the  proposal extends the requirement to have a responsible 
 
2 For previous statements follow the thread under ID 762 . G/TBT/M/88  
 
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  person in the European Union laid down in the Market Surveillance Regulation also to non -
harmonized products.  
2.6.  The proposed random testing obligations would ensure that the responsible economic operato rs 
carry out sample testing of randomly chosen products made available on the market. It would not 
require the systematic sample of all products. The objective of such tests is to ensure that products 
are safe and comply with the general safety requirement . The Commission has carried out a thorough 
impact assessment of the proposal (including its financial impacts) and published it together with 
the proposal (SWD(2021) 168 final).3 The costs and regulatory burdens associated with this proposal 
have been ke pt as limited as possible in order to ensure the objective proportioned by the proposal. 
The Commission proposed a six -month transition period in Article 47 of this proposal. This 
transitional proposal is considered proportionate given that the General Pro duct Safety Regulation 
does not create a completely new system, but revises the framework provided under the current 
General Product Safety Directive. Moreover, it also provides for alignment to the harmonised product 
area established in the Market Surveil lance which is already applicable. The European Commission 
has launched an EU funded awareness raising project for Chinese manufacturers, exporters, online 
sellers and other economic operators of the supply and distribution, about safety requirements for 
non-food consumer products sold in the European Union. The core of the "Safe non -food consumer 
Products in the EU and China " (SPEAC) project is the systematic approach to address relevant topics 
of product safety and the EU requirements in the prioritised a reas (toys, electrical appliances, 
childcare articles, etc.) and to customise the trainings to the actual stakeholder needs. For more 
information please visit the project's website.4 
2.1.3.2   European Union - Draft Commission Regulation amending Annexes II and V t o 
Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards 
maximum residue levels for clothianidin and thiamethoxam in or on certain products, 
G/TBT/N/EU/908  (ID 7635) 
2.7.  The representative of Kenya  provided the following statement. On 6 July 2022, EU notifi ed the 
WTO Members under TBT about lowering MRLs for two Neonicotinoids, with the stated aim to 
"addresses an environmental concern of global nature, that it is the decline of pollinators worldwide. 
It concerns the review of all existing Maximum Residue Li mits (MRLs) for clothianidin and 
thiamethoxam to the Limit of Quantification in accordance with Regulation (EC) No 396/2005. " The 
draft regulation sets out details of a proposed measure lowering all MRLs (including Import 
Tolerances (ITs) and Codex MRLs fo r insecticides; clothianidin and thiamethoxam in domestic and 
imported food and feed to the Limit of Quantification (LoQ). While several references are provided 
in the draft regulation including Inter -governmental Science -Policy Platform on Biodiversity an d 
Ecosystem Services (IPBES) (2016), Kenya notes that the assessment report of the IPBES on 
pollinators, pollination and food production confirms that one single factor alone cannot explain the 
pattern of bee colony decline observed in some countries, whil e bee colonies increase in others. 
Hence there is no confirmed global environmental risk arising from the two substances. The EU 
measure therefore raises serious concerns of inconsistency with the TBT Agreement Article 2.2.  
2.8.  No other data available would un derpin the assertion that there is a global environmental risk 
that would remain unmanaged by the current established risk mitigation measures implemented by 
the respective regulatory approvals by non -EU countries. Kenya takes cognisance of the fact that 
environmental protection is a legitimate objective under the WTO TBT Agreement. However, the EU 
regulations as proposed are more trade restrictive than necessary to fulfil a legitimate objective. It 
also fails to take into consideration, the Good Agricultur al Practices (GAP) for legal uses in non -EU 
countries. Kenya is an agriculturally based economy, and the products are an integral tool in 
achieving food security and meeting public health objectives. Technical regulations should be based 
on international s tandards where they exist (Article 2.4 of the TBT Agreement), in the assessment 
of suitability for authorization of active substances. The European Union's policy on regulation of 
pesticides is in contravention of International Standards and principles of risk analysis (Article 5 of 
SPS Agreement) and the Risk Analysis Principles applied by Codex, in particular the Codex 
Committee on Pesticide Residues (CCPR). Kenya is concerned that by this proposed regulation 
coming into force, it sets a negative preceden t for application of similar approaches for regulating 
 
3 https://ec.europa.eu/info/sites/default/files/impact_assessment.pdf   
4 www.speac -project.eu   
5 For previous statements follow the thread under ID 763 . G/TBT/M/88  
 
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  other substances beyond the borders of the EU based on environmental factors in future. This will 
have significant impact on international trade.  
2.9.  The proposed regulation notified under the TBT Agreement affects measures applied under the 
SPS Agreement which is contrary to Article 1.5 of the TBT Agreement. The proposed regulation 
acknowledges that existing EU -MRLs and Codex MRLs are safe for consumers; thereby 
acknowledging that the proposed meas ures are expanding the scope of the existing EU MRL 
regulation beyond protection of consumer and animal health. The proposed amendments on MRLs 
are more stringent than the provisions of the EU MRL Regulation 396/2005. The EU measure raises 
serious concerns  of inconsistency with the TBT Agreement Article 12.3 and GATT 1994: (i) The EU 
measure has the effect of discriminating against the agricultural exports products from developing 
countries, since the active substances are in use for agricultural production  in these countries; 
(ii) the EU measure ignores production and regulatory conditions in non -EU countries; (iii) the EU 
fails to take into account the special development, financial and trade needs for developing country 
members.  
2.10.   Products containing clothi anidin have been registered as a Seed Dresser Insecticide for the 
control of Aphids and thrips, for reduction of Maize Lethal Necrosis Disease (MLND). MLND has 
contributed to the reduction of Kenya's maize production in Kenya, with areas affected recording  
losses of up to 100%. In Kenya, maize is a staple food that constitutes a significant basis of food 
security and is cultivated by both large and small -scale farmers. More than 90% of the Kenyan 
population relies on it for income, human consumption, and ra w material for industrial uses. Among 
the diseases, MNLD has emerged as the single most important production constraint in maize. Kenya 
requests the European Union to consider the withdrawal of the Regulation as the measure is more 
trade restrictive than n ecessary.  
2.11.   The representative of Indonesia  provided the following statement. Indonesia thanks the EU 
for its notification of "Draft Commission Regulation as regards maximum residue levels for 
clothianidin and thiamethoxam " to the WTO as G/TBT/N/EU/908  on 6 July 2022 which amended 
Regulation (EC) No. 396/2005. Indonesia has submitted its comments in response to the EU on 22 
September 2022 but has not yet received any response to the question. This regulatory amendment 
addresses a global environmental issue, namely the decline of pollina tors worldwide. Regulation (EC) 
No. 396/2005 is a regulation directed at consumer protection. However, environmental 
considerations are not within the scope of Regulation (EC) No 396/2005 as this aspect is fully covered 
by Regulation (EC) No 1107/2009 for plant protection products reviewed and registered for safe use 
in the EU. Therefore, data on environmental impacts are usually not required to be submitted in the 
MRLs application documents. A similar regulatory approach is generally applicable in non -EU 
countries where environmental data is not part of the procedure for regulating import tolerances, 
but robust environmental risk assessment standards are in place for the registration and use of 
pesticides in most countries, including risk assessment for pol linators.  
2.12.   The agenda for the meeting of the Standing Committee on Plants, Animals, Food, and Feed 
(SCoPAFF) in April 2022 includes Articles 14(1)(a), 18(1)(b), and 49(2) of Regulation (EC) 
No 396/2005 as the basis for lowering MRL for the NNIC class of act ive substances. Regulation (EC) 
No 396/2005 was found to lack a solid legal foundation for implementing environmental 
considerations under EU legislation. This regulation does not appear to provide a basis for 
considering measures to regulate and impact th e use of plant protection products registered outside 
the EU. In Indonesia, clothianidin and thiametoxam are used for both domestic and export crops 
such as palm oil, cocoa, coffee, tea, and mango. The use of clothianidin and thiametoxam refers to 
the inte rnational standard such as CODEX and pays attention to the application of Good Agricultural 
Practices (GAP). Lowering the MRL is considered to have a negative impact on agricultural 
commodity exports to the EU. Finally, the EU's proposed measures could res trict trade in agricultural 
products that comply with international MRL standards, disrupt production, and affect the livelihoods 
of small agricultural producers. MRLs are international trade standards that protect consumers. 
Determining the value of MRLs for environmental reasons contradicts the objectives of the MRLs 
themselves. If the EU's MRLs, especially clothianidin and thiamethoxam, are implemented, it will 
have serious implications for farmers in developing countries who export to the EU because it will 
prevent farmers from using certain technologies that are useful for producing agricultural 
commodities economically.  
2.13.   Indonesia already has a regulatory system in place for plant protection products (pesticides), 
ensuring that the products used by farm ers have been registered after meeting the registration G/TBT/M/88  
 
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  requirements related to human and environmental safety. The EU in this regard, must respect the 
needs of each country to set consumer and environmental protection standards based on local 
conditions a nd in line with international standards. We hope that the EU will take these into account 
and consider the ability of non -EU countries, especially developing countries, to comply with this 
regulations.  
2.14.   The representative of the United States  provided the f ollowing statement. The United States 
thanks the EU for its notification of "Draft Commission Regulation as regards maximum residue 
levels for clothianidin and thiamethoxam", to the WTO as G/TBT/N/EU/908  on 6 July 2022. The 
United States submitted its comments in response to the EU o n 2 September 2022. We share the 
EU's concerns about pollinator health and are actively working to protect bees and other pollinators 
in the United States. To date, the global scientific and regulatory community has found that complex 
interactions among mu ltiple factors affect pollinator health, including the health of bees. Given the 
critical importance of the pesticides identified in the Regulation as part of integrated pest 
management, or IPM, programs on crops that are exported to the EU by many countri es, the 
proposed measure appears to pose a significant obstacle to international trade and production of 
agricultural products.  
2.15.   Use of pesticide MRLs is intended to manage the food safety risk of treated imported food 
products upon arrival into a market. M RLs are not intended to be an environmental safety 
management tool, and their use for this purpose may have unintended consequences that could 
undermine the development and use of international standards for food safety. In our comments, 
we noted to the EU  that we understand the 2018 EFSA risk assessments for this measure to be 
limited to studying only a small number of pollinators and food examples. Could the EU explain how 
the conclusions from these risk assessments support the reduction of MRLs to the li mit of 
determination (LOD) for the impacted products? We further ask the EU to provide any analysis and 
studies that it conducted to review production systems outside the EU. The United States notes that 
the studies cited in the 2018 EFSA risk assessments only reviewed European production systems 
and pollinators found in Europe.  
2.16.   More specifically, the United States requests that the EU please provide the scientific or 
technical information that demonstrates how the reduction of these MRLs to the LOD contrib utes to 
the objective of the protection of pollinators, including bees. Given the deficiencies in the 2018 EFSA 
risk assessments outlined above, we are concerned with respect to the objective criteria the EU will 
use in assessing applications for import to lerances under this Regulation and ask that the EU provide 
more detailed information on such criteria. In the absence of scientific or technical information 
indicating how the reduction of MRLs to the LOD on the impacted products contributes to the 
objecti ve of protection of pollinators, including bees, the United States requests that the EU maintain 
its current MRLs for clothianidin and thiamethoxam. Global environmental challenges require 
collaboration across the global community; unilateral approaches ba sed on incomplete science may 
complicate or further delay meaningful progress on these pressing issues while unnecessarily 
affecting agricultural production and trade. In place of the EU's proposed regulation, the United 
States would welcome a collaborativ e approach to protecting pollinators and the opportunity to 
contribute resources, scientific expertise, and new ideas.  
2.17.   The representative of Ecuador  provided the following statement. My delegation wishes to 
express its concern about the measure notified by  the European Union regarding the protection of 
pollinators by lowering the MRLs for neonicotinoids (clothianidin and thiamethoxam), of which this 
Committee was notified  on 6 July 2022.  The EU's regulatory proposal would not appear to be properly  
in line w ith Articles 2.2, 2.4 and 12.3 of the WTO Agreement on Technical Barriers to Trade and 
GATT 1994. It infringes on the regulatory policy powers of its trading partners, who sovereignly set 
the conditions for food production and agricultural activity in thei r own jurisdictions according to 
their geographic differences, ecosystem conditions, agricultural output, scientific capabilities and 
development.  Thiamethoxam is effective against nematodes and black aphids in banana production, 
and against thrips and aph ids in flower production. It also leaves significantly less residue in the 
environment and decomposes much faster than other products.  According to the Rainforest Alliance, 
the risk from the use of thiamethoxam in banana cultivation has been mitigated and there have 
been no reports of direct harm to bee populations. It also indicates that the transitional period for 
the development of a new plant protection product should be at least 36 months; a shorter time is 
not sufficient to comply with the new MRLs, g iven the harvest periods and the stage at which the 
agrochemicals are applied.  Lastly , as this is a measure that applies to third countries, the European 
Union needs to carry out an analysis of the impact it would have on farmers in third countries, as G/TBT/M/88  
 
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  not having these substances as a means to protect their crops would have an adverse effect on 
small -scale producers. The European Union is invited to address the concerns expressed by a number 
of Members on this matter, in order to avoid unnecessary restricti ons on trade.  
2.18.   The representative of Australia  provided the following statement. Australia thanks the 
European Union (EU) for notifying Members of the proposed regulation in document G/TBT/N/EU/908  
on the draft re gulation for the neonicotinoid insecticides clothianidin and thiamethoxam, to which 
Australia provided comments. Australia reiterates the concerns expressed in our submission. The 
draft regulation considers environmental impacts in exporting countries when  setting maximum 
residue levels (MRLs) and assessing requests for import tolerances. Australia recognizes the right of 
WTO Members to regulate agricultural imports in a manner that protects animal, plant and human 
health and the environment. However, Membe rs are also bound by WTO obligations, particularly in 
relation to undertaking science -based risk assessments and ensuring that measures are no more 
trade -restrictive than necessary. Australia does not support using MRLs on imported products to 
achieve envi ronmental objectives outside the EU's borders. This extra -territorial approach impacts 
the ability of third countries to implement environmental policies consistent with their unique 
environmental circumstances.  
2.19.   National authorities of third countries are best placed to ensure that pesticide application is 
undertaken in a responsible and sustainable manner in each country, and in accordance with their 
unique environment. Australia is concerned about the limitations of the 2018 European Food Safety 
Authority  risk assessments cited by the EU in the draft regulation. These studies have been used to 
support a link between the lowering of MRLs to the limit of determination and pollinator health. We 
request the EU provides robust scientific evidence in support of this conclusion. Australia also 
requests the EU provide information on the health of pollinators in all trading countries where the 
new MRLs are likely to apply. The EU may wish to consider restricting the new MRLs to only those 
countries where it has robu st evidence to support its policy objective. We look forward to continuing 
to engage with the EU on this important topic.  
2.20.   The representative of Peru provided the following statement. Peru submits to WTO  Members 
its trade concern regarding the draft amendme nt to Regulation (EC) No 396/2005, which includes 
the elimination of maximum residue limits (MRLs) for the molecules clothianidin and thiamethoxam, 
which would result in a ban on exports to the European Union of agri -food products containing any 
detectable  residues of those molecules. Peru considers that while members of the European Union 
have the right to apply sanitary or phytosanitary measures that they consider appropriate to their 
level of protection, such measures should be based on scientific princi ples and "risk" assessment 
procedures, not just on the "hazard". Furthermore, the measures adopted should not be more trade 
restrictive than necessary. It is understood that the current EU regulation for MRLs is based, as 
internationally agreed, on the pro tection of the health of food consumers and not on environmental 
criteria, for which there are other appropriate regulatory frameworks and multilateral forums for 
discussion and negotiation.  
2.21.   In addition, the European Union's proposal to use non -tariff barr iers to trade to protect the 
environment ignores and invalidates the adequacy of Peru's regulatory policies, which sovereignly 
establish the conditions for food production and agricultural activity in the country. The European 
Union's regulatory proposal g oes against Articles 2.1, 2.2 and 12.3 of the WTO  Agreement on 
Technical Barriers to Trade and GATT 1994, as it discriminates against third countries by causing a 
disproportionate impact and ignoring their regulatory and production conditions; furthermore,  nor 
would the alleged risk of using the active substances outside the European  Union cause any risk 
within the European Union. The same regulatory proposal concedes that both the current European 
MRLs and those contained in the Codex Alimentarius are safe  for consumers. In addition, as part of 
the environmental risk assessment of the active ingredients clothianidin and thiamethoxam, the 
environmental authority of the agricultural sector requires that registrants comply with an 
environmental management plan , which must contain environmental control and contingency 
measures, which are intended to control identified environmental risks; such companies must have 
a solid organizational structure at the regional and/or local level and be prepared to address 
contingencies at any stage of the product's life cycle. Lastly, the measure in question should have 
been notified for discussion in the SPS Committee, since the purpose of Regulation No. 396/2005, 
which is set to be amended, is to ensure a high level of protect ion for the public health of consumers 
and animal health.  G/TBT/M/88  
 
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  2.22.   The representative of China  provided the following statement. China appreciates the emphasis 
placed by the EU on the importance of protecting pollinators including bees. We would like to draw 
attent ion to the following points which may need reconsidering for better and more appropriate 
regulation. Firstly, it is the international community's general agreement that MRLs are in place to 
protect consumer health and facilitate fair trade of food. However , scientific evidence and consensus 
are absent that problems like decreasing numbers of bees could be addressed through MRL measures 
relating the two pesticides clothianidin and thiamethoxam. It's still a matter of academic debate 
whether neonicotinoid pes ticides are the main cause of the decline in bee colonies. Some studies 
suggest the combination of parasites, pesticides, pollination deficiency, and climate change as the 
real reason for decreasing number of bees. Currently, revoking or modifying MRLs on the grounds 
of addressing pollinator decrease would give the impression of arbitrarily creating trade barriers. We 
recommend that the EU provide data and reports on bees' risk assessment regarding the MRLs of 
the two pesticides. Secondly, as the EU has pre viously cancelled the registration requirement for 
clothianidin and thiamethoxam, it would not affect local producers. However, it would indeed 
constitute a de facto trade barrier for other Members who are using the two pesticides under scientific 
risk eva luation.  
2.23.   The representative of Colombia  provided the following statement. Colombia would like to 
express its concern about the European Commission's draft regulation amending Annexes II and V 
to Regulation (EC) No. 396/2005 of the European Parliament and o f the Council as regards maximum 
residue levels (MRLs) for clothianidin and thiamethoxam in or on certain products. This is the first 
time that changes are being proposed to an MRL based on environmental criteria in order to avoid 
or mitigate the risk of p esticides in food for human consumption, and not based on health criteria. 
Therefore, the measure should have been notified in the framework of the SPS  Committee, as its 
objective is to ensure consumer and animal health. In the light of the above, we belie ve that the 
European Commission's draft regulation should be reassessed in the framework of the WTO's 
international regulations, in line with international recommendations of the Codex Alimentarius on 
MRLs. The WHO and FAO jointly assessed the aforemention ed substances  under the Codex 
Alimentarius and determined that they posed no risk for consumers. It should also be noted that 
there are scientific opinions from the European Food Safety Authority (EFSA) suggesting that there 
are no toxicological aspects in  these molecules that could affect human health. Therefore, Colombia 
believes that the draft regulation on MRLs should take into account scientific evidence and be subject 
to a definitive risk analysis, which can demonstrate the implied risk of using them and the level of 
residue at which the compounds would affect consumers.  
2.24.   In addition, we are of the opinion that the regulatory adjustment related to setting an MRL 
using environmental criteria constitutes an unnecessary and unjustified barrier to trade, an d has a 
significant negative impact on countries that market products in the European Union, adversely 
affecting people who earn their living from crop production. Moreover, MRLs are not intended to 
protect the environment, so this is an ineffective and in appropriate approach to achieving the 
European Union's objectives. It would be necessary to determine whether there are effective and 
appropriate international standards for this purpose; in which case, we believe that the European 
Union should submit the international reference standard or the scientific studies that provide the 
basis for the aforementioned measure. It should be noted that Colombia is convinced of the need to 
protect the environment, but it is important that the risk measurement be based o n conclusive 
analyses, following a scientifically validated methodology. Lastly, this process of converting to a 
sustainable food system seems to ignore the implications of these transformations, as it imposes 
limitations on the use of pesticides and ferti lizers because of environmental factors, depriving 
farmers of essential tools that ensure the health of their crops. This may result in a substantial 
reduction in the supply of a crop, affecting its price and, consequently, its consumption. Not to 
mention the impact on farmers' income, as they will be unable to sell their produce, causing their 
quality of life to decline. In view of the foregoing, we invite the EU to review this regulatory 
amendment and to consider other relevant forums for discussions, suc h as the Conferences of the 
Parties to the Rotterdam Convention and to the Stockholm Convention, where decisions around 
including new substances are adopted.  
2.25.   The representative of Costa Rica  provided the following statement. Costa Rica wishes to 
support th is trade concern raised by Kenya and supported by a large number of Members, against 
the EU proposal to set maximum residue levels (MRLs) as mechanisms for achieving environmental 
objectives. Broadly speaking, Costa Rica 's policy is aligned with the EU's o bjective of prioritizing 
environmental protection, the fight against climate change and sustainable economic development, 
as the only viable path forward for the future of our planet. However, under no circumstances must G/TBT/M/88  
 
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  achieving these objectives come at the expense of the multilateralism and fundamental obligations 
that underpin this Organization. The Agreement on Technical Barriers to Trade clearly sets out the 
objectives that the technical regulations, standards and conformity assessment procedures may 
legitimately fulfil. We are not sure which legitimate objective could justify revising an MRL, an issue 
linked to food safety and the protection of human health, which falls within the scope of the SPS 
Agreement. Therefore, we are struggling to understand EU notification G/TBT/N/EU/9 08, as 
although, this notification proposes reducing the MRLs for clothianidin and thiamethoxam , it was 
submitted to the TBT Committee and not to the SPS Committee. In this notification, the EU states 
that its motivation is a "an environmental concern of global nature". Among the legitimate objectives 
of the TBT Agreement, we cannot find global environment concerns as a justification for a measure 
covered by this Agreement. Addressing environmental concerns of a global nature is also a matter 
of the utmost  importance to Costa Rica. However, it is not clear how this objective falls within the 
scope of the SPS and TBT Agreements. We would like to thank the EU in advance for its explanations 
with regard to this concern, which Costa Rica raises along with other  Members  
2.26.   The representative of Canada  provided the following statement. Canada, like other Members, 
is concerned with the European Union's proposal notified to the WTO TBT Committee in July 2022 
under G/TBT/N/EU/908 , whereby the EU is considering lowering the MRLs for clothianidin an d 
thiamethoxam to the Limit of Quantification (LOQ) based on environmental concerns for the global 
pollinator population.  While Canada supports efforts to protect and maintain the global population 
of pollinators, we remain concerned with the approach that  the EU is proposing to take through this 
regulation to address the issue. By reducing neonicotinoid MRLs to default values when no dietary 
risks of concern have been identified, Canada is of the opinion that the European Union is 
unjustifiably applying th eir domestic legislation on an extraterritorial basis, which is incompatible 
with WTO obligations and could unnecessarily restrict trade. If a pesticide does not have dietary 
concerns and poses no risks to EU consumers, the EU should maintain the MRLs or h armonize with 
Codex. Canada is also concerned with the EUs use of emergency authorizations for its own member 
States.  
2.27.   The EU has stated repeatedly that the main intention of this regulation is to ensure food and 
feed consumed in the EU does not contribute to the global decline of the pollinator population. 
However, with the sustained use of emergency authorizations granted in member States for these 
two pesticides, it is not clear to Canada how the proposed rule would still contribute to that objective, 
as Europeans will continue to consume food and feed produced using neonicotinoid innovation, 
whereas imports that use these products will be banned. Canada has a robust regulatory system 
and is confident in the mechanisms we have in place in Canada to protect  consumers and the 
environment. We protect human health and the environment by conducting rigorous scientific 
evaluations of the risks associated with pest control products, which is critical to enabling access to 
the pest management tools necessary to add ress pest pressures specific to the Canadian climate. 
Canada has undertaken extensive research and mitigation techniques related to the use of 
neonicotinoids and as a result, has successfully reduced bee incidents over 80% since 2014.  
2.28.   The European Union co uld not only benefit from Canada's best agricultural practices, but could 
maintain the MRLs for neonics, not unnecessarily restrict trade, and collaborate with Canada and 
other WTO Members to mitigate the risk to pollinators and address the impact on polli nators globally. 
Canada reiterates its concern that the EU's intention to impose its own regulations to trading partners 
does not reflect the unique circumstances of countries, nor is it aligned with the science available 
from other Members such as Canada.  It is our hope that the European Union will take these concerns 
seriously and work with Canada and other interested Members in finding a science -based, WTO -
compliant way to achieve its objective.  
2.29.   The representative of India provided the following statemen t. India would like to thank the 
EU for notifying Members via G/TBT/N/EU/908  on MRLs for clothianidin and thiamethoxam. India 
understands that the EU is considering lowering existing MRLs for pesticides no longer approved in 
its jurisdiction due to environmental concerns – such as so me neonicotinoid insecticides, to the 
default value and not considering new requests for import tolerances. This approach is not restricted 
to this notification, and for many products, the residual pesticide limits have been set at 0.01 mg/kg. 
EFSA has not ed that the default MRL of 0.01 mg/kg applies to nearly 690 pesticides which are not 
explicitly mentioned in the MRL legislation. As is evident from the comments by other trading 
partners, there are concerns with the setting of default MRL for many product s because it imposes 
a standard that may need to be sufficiently scientifically founded on imports from other countries. 
Some of the products not grown in the EU face these thresholds. This disregards the competence of G/TBT/M/88  
 
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  the other countries' chemical regulat ors and artificially subjects them to a requirement that is neither 
scientific, evidence -based, nor practicable to be commercially employed. EU often cites concerns 
related to protecting its citizens. However, even that remains questionable as citizens of other 
countries are found to be comfortable without those requirements; at the same time, the studies 
relied on by the EU are noted to need to be sufficiently representative of the EU citizen pool in some 
cases. For cases where environmental concerns are c ited, India reminds the EU that it is important 
to respect each Member's right to set its regulations for environmental protection.  
2.30.   This approach adopted by the EU also fails to recognize the efforts of international scientific 
panels and standard -setting  bodies – such as the Joint FAO/WHO Meeting on Pesticide Residues and 
the Codex Alimentarius – in establishing a safe and harmonized level of pesticide residues in 
agricultural products. In these circumstances, India urges the EU to revise its practices an d avoid 
unnecessary trade disruption, ensuring compliance with its obligations under the WTO while setting 
MRLs and considering requests for import tolerances. India also requests the EU to respect the 
regulatory authorities of other countries and their po sitions, especially when more than a few 
countries share a common understanding and not to impose arbitrary MRL standards preventing 
unnecessary disruption to trade in safe products.  
2.31.   The representative of Paraguay  provided the following statement. Paraguay  notes that the EU 
intends to use the MRLs for clothianidin and thiamethoxam, not to protect European consumers, but 
as a means to regulate the use of neonicotinoids in production processes and methods in 
third countries. In Paraguay's view, the TBT Agreem ent was not designed to accommodate measures 
with clearly extraterritorial objectives.  Paraguay also has serious concerns regarding the 
compatibility of the notified EU measure with obligations relating to market access and 
non-discrimination under WTO rul es. Paraguay shares a genuine interest in environmental and 
biodiversity conservation, and accords primacy to the protection of human, animal and plant health, 
including protection of pollinators, which also play a key role in global food production and co ntribute 
to higher yields of agronomically important crops.  However, like Paraguay, each country has 
particular needs and challenges in its agricultural production, based on its geography, ecosystem, 
and local scientific capacities, as part of the quest to  attain and maintain sustainability in agriculture. 
This situation is reflected in the evidence -based regulatory frameworks applied to registration 
processes to assess the risks of pesticides and their uses, including the assessment of risks to the 
environ ment and pollinators.  By seeking to impose its environmental standards on third countries, 
the EU ignores and invalidates such local and even regional regulatory policies, threatens the 
implementation of environmental measures and policies that are compati ble with the particular 
situations of each country in terms of climatic and socio -economic conditions and pest prevention, 
etc., and fails to take into account common but differentiated responsibilities.  
2.32.   How does the EU intend to address this and the speci al financial, trade and development 
needs of developing and LDC members in accordance with Article 12.3 of the TBT Agreement?  
Paraguay does not consider MRLs to be a suitable tool to address environmental challenges in other 
countries, for which there are other appropriate regulatory frameworks and multilateral forums for 
discussion and negotiation.  With regard to these substances there are also different mitigation 
options to manage potential risks to pollinators from the use of clothianidin and thiamethox am, 
ranging from clear and precise instructions on labels to the implementation of good agricultural 
practices in all processes.  Practices, such as applying the substances in the early morning or late 
afternoon when there is a lower prevalence of pollinato rs; not using the substances at the flowering 
stage of crops; removing flowering weeds from the field; reducing dust when planting treated seeds, 
are effective means of risk mitigation as they limit exposure.  Multiple independent studies by 
scientific regu latory authorities around the world agree that neonicotinoid insecticides can be used 
responsibly without causing unacceptable risks to bees or other pollinator species in the field. Several 
specific studies were included in the multiple comments submitted  by WTO members to notification 
G/TBT/N/EU/908 . 
2.33.   Does the EU consider that the reduction of MRLs is appropriately linked to the objective 
pursued? In particular, bearing in mind that:  a crop not treated with these substances may have 
MRLs above the limit of quantitation (LOQ), for example, if an adjacent field was treated;  controlled 
use of the substances may have no impact on pollinators and still have MRLs above the LOQ.  In field 
7 of notification G/TBT/N/EU/908 , the EU states that an objective of the measure is "to ensure that 
also commodities imported into  the European Union do not contain residues resulting from good 
agricultural practices based on outdoor uses of clothianidin and/or thiamethoxam".  Could the EU 
clarify how it will identify products with MRLs above the LOQ due to indoor use or other methods  G/TBT/M/88  
 
- 11 - 
 
  that do not affect pollinators?  Imposing restrictions on international trade will, in effect, make 
farmers in Paraguay and the region less competitive than farmers in Europe who do not have to 
contend with the same pests and climatic conditions to produce  food, and who can also benefit from 
emergency authorizations to continue using these substances.  This can be seen from the emergency 
authorizations granted for these substances since the ban and the end of the grace period for their 
use in the EU:  Thiamet hoxam: 51 emergency authorizations for different crops since the ban and 
end of the grace period for the substance in the EU (30/04/2019) (Austria, Belgium, Czech Republic, 
Germany, Denmark, Spain, Finland, France, Croatia, Hungary, Lithuania, Latvia, Pola nd, Romania, 
Slovakia), including the most recent one authorized for the period February –June 2023.  Clothianidin: 
20 emergency authorizations for different crops since the ban and end of the grace period for the 
substance in the EU (31/01/2019) (Austria, B elgium, Czech Republic, Denmark, Spain, Finland, 
Poland, Romania), including the most recent one already approved for the period 
February -May 2023. And these are the ones authorized when the grace period ended; those 
authorized for use after the grace peri od are even more numerous, given that some emergency 
authorizations were granted before 31/01/2019 but their use began after that date.  How are these 
emergency authorizations compatible with the non -discrimination obligation?  What is the average 
approval t ime for an emergency authorization?  What is the average cost of the emergency 
authorization approval process?  
2.34.   These questions were repeatedly raised in other committees, but the EU response was limited 
to noting that emergency authorizations are issued by EU member States, and each member State 
determines the length of the evaluation process and the costs.  We reiterate these questions, 
however, and hope to receive answers to them, especially since EU  members are also members of 
the WTO in their ow n right and it may be necessary to start asking questions to each of them 
separately.  The EU insists that, although emergency authorizations are the responsibility of the 
members, the European Food Safety Authority (EFSA) reviews them and rules on whether they were 
properly justified.  However, we see that there are no restrictions on members that continue to 
approve emergency authorisations for the same substances, for the control of the same pests, and 
on the same crops for which the EFSA concluded that th e approval was not properly justified.  The 
EFSA further considers that emergency authorizations are justified when the need to avoid pest 
resistance is proven and if there are no chemical alternatives to control a particular pest. The same 
arguments are us ed by Paraguay and other members for whom there is no possibility of emergency 
authorizations.  Lastly, with regard to transparency and the time limit for commenting on draft 
regulations, Paraguay, like several other Members, submitted comments on notificat ion 
G/TBT/N/EU/908  within th e established deadline but, according to information gathered, on 
27 September  2022, only 23  days after the end of the comment period, the Standing Committee on 
Plants, Animals, Food and Feed (ScoPAFF) of the EU approved the proposal to reduce the MRLs for  
these substances without modifications, which again leads us to think that notifications and comment 
periods are merely formalities and not intended to be taken into account.  
2.35.   The representative of Brazil  provided the following statement. Brazil thanks the  European 
Union for the opportunity to comment on the proposed regulation notified as G/TBT/N/EU/908 , which 
withdraws the approval of the active substances thiamethoxam and clothianidin and restricts the 
maximum residue levels in or on certain products. We would like to refer to the comments we have 
submitted to the EU. Brazil understands that the EU's current proposal goes against the commitment 
in Article 2.2 of the TBT Agreement, as it is out of the scope of such Agreement to support unilateral 
policies aimed at protecting the envi ronment in third countries. Besides the need for further 
discussion, under sound scientific basis, about the risks that thiamethoxam and clothianidin may 
have on bees' population worldwide, Brazil understands that one could not expect to extend to all 
countries of the world trade -restrictive measures that do not consider the variety of local conditions, 
including climate and soil. Furthermore, there are different needs and challenges posed by 
agricultural production in each country.  
2.36.   The EU affirms that its restrictive measure would seek to avoid the transfer of adverse effects 
on bees from food production in the EU to food production in non -EU countries. However, for Brazil, 
this approach is not properly considering that many countries, including Brazil, hav e rigid technical 
procedures for approving substances. Furthermore, Brazil believes that, due to its extraterritorial 
effects, the EU proposed regulation goes against the rules and jurisprudence of the multilateral trade 
system. To highlight how it is uncl ear for Brazil that the trade restrictions proposed by the EU would 
be justified, thiamethoxam is one important substance used in control strategies of pests such as 
the citrus psyllid, an insect that transmits the greening disease. Recognized by the Europ ean Food 
Safety Agency (EFSA) as a priority pest for control in EFSA's List of Priority Pests of October 2019, G/TBT/M/88  
 
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  greening is a major cause of losses in orange production not only in Brazil, but worldwide. In Brazil, 
the State of São Paulo is the main citrus juice producer and it is also where 84% of honey production 
is concentrated. In that state, there is no evidence of a decline in the number of pollinators. On the 
contrary, honey production in that region has increased by about 136% in the last 15 years.  
2.37.   We also have a concern that if the current proposal for restricting the use of thiamethoxam 
and clothianidin becomes the basis for other similar restrictions, farmers in Brazil and worldwide can 
face serious problems that will affect productivity and their  capacity to contribute to global food 
security. Brazil appreciates the opportunity to discuss this issue with the EU and calls for the 
European Commission to consider a more balanced approach that harmonizes with the Codex 
Alimentarius' recommendations fo r clothianidin and thiamethoxam MRLs. Brazil also appreciates the 
opportunity to provide comments and we would be grateful if they can be taken into account and 
replied to before the adoption of the notified draft.  
2.38.   The representative of New Zealand  provide d the following statement. New Zealand supports 
the EU's overarching ambition to mitigate climate and environmental challenges as set out in the 
policies presented through the Green Deal. However, New Zealand holds concerns that unilaterally 
imposing presc riptive import measures, without consideration of the variations in geographic and 
climatic contexts between various countries' production systems may not successfully address global 
environmental challenges. New Zealand encourages the EU, like all WTO Mem bers, to address global 
environmental issues, including sustainable pesticide use, by working with trade partners in 
multilateral fora and recognizing that different production and regulatory systems can deliver 
similarly desirable environmental outcomes. Such an approach recognizes that there is no "one -size-
fits-all" model for addressing global environmental issues and that tailored solutions, accounting for 
differences in production systems can be more effective and durable in delivering desirable 
enviro nmental outcomes. We further encourage Members to use measures that are founded on 
sound science, are risk based, take a least trade -restrictive approach, and which are appropriate to 
achieve the desired outcome. International limits and guidance should be  adopted where available. 
New Zealand is also interested in understanding the EU's rationale and justification for using an SPS 
tool to introduce proposed measures with the stated aim of addressing a global environmental 
concern.  
2.39.   The representative of South Africa  provided the following statement. South Africa thanks all 
Members that have spoken before us and would like to table comments and clarity seeking questions 
to the European Union (EU) Regulation on import tolerance regarding Maximum Residue Levels 
(MRLs) for clothianidin and thiamethoxan (pesticide and active substance) in or on certain products. 
South Africa appreciates that the EU notified the Committee regarding the proposed measure to 
lower MRLs for clothianidin and thiamethoxan substance to the  limit of qualification in accordance 
with EU Regulations (EC) No. 396/2005. South Africa understands that the EU intends to address an 
environmental concern of a global nature namely the decline of pollinators worldwide. South Africa 
shares the EU Commiss ion's goals for food systems transformation, and the commitment to address 
climate change and biodiversity loss by continuing to pursue more sustainable and resilient food 
systems. However, South Africa recognizes that Members have unique sustainability ob jectives and 
challenges. Amongst other related climate challenges, South Africa has high pest and diseases 
pressure due to the combination of heat, humidity and moisture emanating from different weeds, 
pests and fungi. Addressing these opportunities requir es the use of diverse methods, tools and 
technologies to sustainably meet the world's growing demand for food and feed in the face of climate 
change. South Africa promotes more sustainable and good agricultural practices and food systems 
that emphasize the  best mix of tools and techniques to achieve more sustainable production 
depending on a Member's varying location, scale and environment.  
2.40.   South Africa notes that the lowering of MRLs for clothianidin and thiamethoxan substances 
expands the scope of existi ng MRLs regulations beyond consumer protection to environmental 
considerations. The proposed measure of lowering (MRLs) for clothianidin and thiamethoxan 
substances will have an adverse effect on agricultural and agri -food exports to the EU. Ultimately, 
the proposed measure may restrict trade of safe agricultural products, disrupt production and 
negatively affect the livelihoods of small and rural producers. South Africa supports transparency, 
science and risk -based decision -making driven by available data to enhance sustainability in 
agriculture and urges the EU to take cognisance of climate conditions, crop -pest matrices and socio -
economic conditions of developing and under -developed economies in the developing and 
implementation of the measure. Additional ly, South Africa requests clarity in the following questions: 
(i) Confirmation that, if this regulation is enforced, the MRLs will decrease to 0.01 mg/kg for all G/TBT/M/88  
 
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  products? If not, what are the applicable product specific levels? (ii) Confirmation that the European 
Union has banned the use of clothianidin or thiamethoxam in all applications, including the use in 
permanent greenhouses. If not, will these products also have to adhere to the new MRLs? (iii) Since 
the EU has implemented the ban on the outdoor us e of clothianidin or thiamethoxam, what 
alternatives are used in the EU and what was the cost implications to farmers?  
2.41.   (iv) The regulations includes the following statement: 5.1. "in order to meet the needs of 
international trade, applications for import t olerances for clothianidin or thiamethoxam may be 
submitted pursuant to Article 7 of Regulation (EC) No 396/2005 and should provide relevant 
information to demonstrate that the Good Agricultural Practices applying for the specific uses of the 
active substa nces are safe for pollinators ". What is the process to be followed and what is the 
proposed turn -around time?  
2.42.   The representative of Uruguay  provided the following statement. Uruguay has submitted 
comments and requests for clarification to the European Unio n (EU) in relation to the planned 
reduction of MRLs for clothianidin and thiamethoxam in or on certain products, due to an 
"environmental concern of global nature", at recent meetings of the SPS, TBT and Market Access 
Committees, as well as bilaterally, as  part of the international public consultation process opened by 
the EU in notification G/TBT/N/EU/908 . We appreciate the opportunity to submit these comments 
and questions, and we continue to await the responses, but we would be particularly grateful if these 
submissions were duly t aken into account during the regulatory process. In this connection, as was 
mentioned by Paraguay, we are concerned by the approval, without amendments, of the proposal 
on 27 September 2022 by the EU's Standing Committee on Plants, Animals, Food and Feed, despite 
the observations made by various trading partners. Uruguay understands that setting MRLs is the 
type of measure intended to protect consumer health from the risks arising from ingestion and that 
it therefore falls within the scope of the SPS Agreem ent. The international reference body for such 
issues is the Codex Alimentarius Commission, where health -related issues are comprehensively 
addressed in relation to the adoption of MRLs. Article 3 (d) of EU Regulation No. 396/2005 on the 
MRLs of pesticides  defines MRLs as: "the upper legal level of a concentration for a pesticide residue 
in or on food or feed set in accordance with this Regulation, based on good agricultural practice and 
the lowest consumer exposure necessary to protect vulnerable consumers ". 
2.43.   The EU itself has repeatedly indicated to us – up to March 2022 – that, as a matter of principle, 
concerns about fixing MRLs for pesticides and any specific issue related to their implementation are 
matters that must be discussed in the SPS Committee, a nd not the TBT Committee. In that 
connection, the European Union has notified the SPS Committee of successive amendments to the 
MRLS for an increasing number of substances. Uruguay shares concerns about promoting the 
protection of pollinators, in line with  environmental and biodiversity protection, and supports the 
establishment of regulatory environments based on scientific criteria, so as to avoid putting food 
security at risk or erecting barriers to trade. Uruguay reiterates its willingness to cooperate with 
other Members to find mechanisms that can be used to achieve these objectives without 
unnecessarily restricting trade, while also ensuring preservation of the environment and the 
protection of human, animal and plant health. It should be noted that, i n Uruguay, the plant 
protection reference products are regulated to ensure the correct, safe and recommended use of 
such substances, as part of a National Environment Plan focused on good agricultural practices. 
However, Uruguay has doubts as to both the a ppropriateness and the legal basis, as per EU 
regulations and WTO standards, of reducing MRLs to the level of detection on the grounds of 
"environmental issues of global concern" or other issues unrelated to human health.  
2.44.   Despite awareness of the importanc e of the environmental aspects , we understand that these 
are not included in the process of establishing MRLs as they are addressed by countries individually, 
on their basis of their own production systems, environmental conditions and policies. This was 
ratified by the Codex Secretariat, which confirmed t hat environmental issues are not currently 
considered in the risk analyses used for plant protection products under the Codex (as indicated in 
paragraph 35 of the report of the 53rd session of the Codex Committee on Pesticide Residues  
(CCPR)). In addition, like other d elegations, such as Canada and Paraguay, we are concerned that 
emergency authorizations continue to be granted to producers from EU member States, which would 
appear to contradict the EU' s stated aim when it introduced this measure, as well as being 
discriminatory in nature. In short, Uruguay is o f the view that MRL measures must be established 
on the basis of a risk assessment with the aim of protecting consumer health and not for 
environ mental protection purposes. Similarly, Uruguay would like to reiterate that the health a nd 
phytosanitary measures adopted or implemented by WTO Members, such as the EU, must be G/TBT/M/88  
 
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  adapted to the objectives set out in Annex A, paragraph 1, to the SPS Agreement , and the other 
substantive obligations under this Agreement, such as those concerning international harmonization, 
the avoidance of approaches that unnecessarily restrict trade, and transparency, as well as 
corresponding obligations under the GATT 1994.  
2.45.   The representative of Argentina  provided the following statement. Argentina fully shares the 
EU’s genuine interest in the strategic importance of pollinators for the global environment, especially 
bees for ecosystems and biodiversity. Likewise, as a major f ood producer, it recognizes the 
significant contribution they make to agriculture and global food security. That is why, like many 
other countries, we have stepped up measures to provide producers with the tools required to 
properly protect plant life, whi ch will enable them to continue producing food. At the same time, by 
adopting good agricultural practices, we are reducing the effects of pollinators from the use of certain 
products. However, everything seems to suggest that  this measure notified by the E U will, rather 
than protecting the environment or pollinators, create an obstacle that will restrict producer third 
countries' ability to export to the EU. Various studies from around the world show that the decline 
in the number pollinators has multifacto rial causes and that the neonicotinoids, clothianidin and 
thiamethoxam, are safe for bees when they are used following good agricultural practices, in addition 
to being absolutely essential for controlling specific pests in extensive farming. In this case,  the 
notified measures are not based on a risk analysis of the toxicity levels in all of the notified food and 
feed and the consequent effect of both neonicotinoids on human health and life within the territory 
of EU member States. Instead, the draft regul ation in question appears to be based on assessments 
of the risk posed by bees being exposed to these neonicotinoids used outdoors, as the EU's stated 
objective is to address an environmental concern of a global nature, namely the decline in pollinators 
worldwide. Seen in this light, the draft regulation would be inconsistent with the EU’s obligations, as 
it has failed to provide a scientific assessment under the terms of the SPS Agreement (Articles 2.2 
and 5.1) to justify the adoption of the measure in que stion.  
2.46.   Irrespective of whether or not the objective being pursued is legitimate, the EU’s measures 
will result in a virtual ban on access to its market for a wide range of food and feed products. This 
would severely affect any exporters to the Community ma rket that failed to ban the outdoor use of 
clothianidin and thiamethoxam in their respective territories within 36 months of the new MRLs 
coming into effect. Therefore, we believe that the trade -disruptive impact that the reduction of the 
MRLs would have o n all the products covered by the measure would not be proportional to the 
objective being pursued by the EU. In this regard, the draft regulation would be contrary to the 
obligations set out in Articles 2.1 (to ensure that measures are applied only to the  extent necessary), 
5.4 (to minimize negative trade effects) and 5.6 (to avoid unnecessary trade -restrictive measures) 
of the SPS Agreement. Equally of concern to Argentina is that implementing the measure would 
amount to a disguised restriction on interna tional trade, contrary to the provisions of Article 5.3 of 
the SPS Agreement. This observation is based on the fact that, on one hand, the performance of 
pollinators does not depend solely on the two substances prohibited by the EU and, on the other 
hand, on the fact that the multiple emergency uses authorized by the EU under conditions that could 
not be extrapolated to third countries, as previously stated by other delegations. This is why we 
have submitted a number of comments on notification G/TBT/N/EU/908  and are awaiting a reply.  
2.47.   The representative of Guatemala  provided the following statement. Guatemala views with 
concern the EU proposal to no t renew  the approval  of clothianidin and thiamethoxam and alter the 
MRLs for those substances on the grounds that they would cause global e nvironmental concerns for 
pollinators, and therefore it will lower the MRLs to the limit of quantification. We are therefore 
submitting comments for public consultation within the WTO process. Linking an environmental 
measure to the use of a pesticide or f ungicide is a major concern, as measures increasingly respond 
to subjective criteria and are not based on a scientific approach. It is important to note that in order 
to be exported to international markets, agricultural products comply with different stan dards and 
good agricultural practices, including the safe use and handling of agricultural inputs. In addition, 
there are programmes in place to mitigate any risk of poisoning and/or contamination that comply 
with all the necessary measures and practices t o ensure their correct use and an appropriate 
production plant environment, including integrated pest management and solid agricultural 
education on the use and effects of agrochemicals. It is also important to note that pollinators are 
key to the producti on phase of agricultural products, such as coffee, particularly during the flowering 
stage. We consider that the European Union has no legal basis to apply environmental measures for 
products outside the European Union, to change MRLs for substances, witho ut scientific evidence 
and risk analysis. The MRL change is linked to ensuring food safety, and the environmental issue is 
not consistent with this legitimate objective, as set out in WTO Agreements. There are currently no G/TBT/M/88  
 
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  chemicals that can replace it, si nce alternative molecules, such as ethoprophos or imidacloprid, are 
also being withdrawn in the EU. There are evaluations of biological alternatives for soil pest control, 
but the findings do not point to adequate levels of efficiency, affecting the level of production.  
2.48.   Thiamethoxan is used for different crops, such as coffee, peas and other vegetables, because 
it is a broad -spectrum insecticide and effectively controls insects resistant to organophosphates, 
carbamates and pyrethroids. It is important to me ntion that farmers are using this substance as a 
substitute for chlorophyriphos, which was also affected by the MRL change. In other words, the 
European Union is leaving only agricultural producers in third countries without alternative 
substances.  In this  regard, Guatemala requests that the European Union provide its legal and 
scientific basis for this decision and conclusive findings demonstrating that the change in the MRL 
will sustain the quantification of pollinators. In addition, the impact of the MRL  change must be 
notified to the SPS Committee.  Guatemala reiterates how important it is to preserve the environment 
and natural resources, as it is to preserve the use of good agricultural practices with the aim of 
allowing a sustainable level of productio n under the production methods in use.  We therefore call on 
the European Union to base its measures on a critical analysis of the risks and impacts of the 
approval and renewal of authorizations for the use of crop protection products. We would be grateful 
if the European Union could indicate what measures it is considering to ensure that this measure is 
not an unnecessary technical barrier to trade. Guatemala calls for the MRL levels to be maintained 
until there is an opportunity for dialogue that considers  not only the trade implications, particularly 
for developing countries, but also real time periods in their implementation.  
2.49.   The representative of Japan  provided the following statement. Japan would like to support 
concerns raised by Kenya and other Member s and make requests to EU regarding its draft regulation 
notified to TBT Committee that proposes to lower the maximum residue levels for clothianidin and 
thiamethoxam in certain products for a reason to protect pollinators outside the EU. First, the 
propos ed measure by EU lowering the MRLs for the purpose of protecting pollinators outside EU is 
clearly a deviation from the current principles for setting MRLs which protects human life or health, 
as well as from the trend of international harmonization on MRL s. When taking a new approach to 
the measures which affect the third countries, such as the MRLs, it should be thoroughly discussed 
with the third countries including at the SPS Committee. Second, judging from the impact on the 
environment and feasibility,  it is obvious that the most reasonable and efficient approach to protect 
pollinators worldwide is not to force a uniform measure set by the EU, but to let each country adopt 
a tailored measure based on such as each country's own climate and soil condition s and pesticide 
use. Last but not least, the proposed measure would be more trade restrictive than necessary to 
fulfill a legitimate objective. Japan would like to request EU to consider Japan's comments on the 
TBT notification to ensure the measures will be consistent with the WTO rules, based on scientific 
principles.  
2.50.   In response, the representative of the European Union  provided the following statement. The 
European Union (EU) would like to thank the intervening countries for providing comments on the 
Notification G/TBT/N/EU/908  about the "Draft Commission Regulation amending Annexes II and V 
to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum 
residue levels for clothianidin and thiamethoxam in or on certain products ". The EU is carefully 
studying all the comments received from a large number of trade partners and business associations 
and it is currently preparing a comprehensive reply to all of the questions raised. All the comments 
were shared and discussed with the EU member States in p reparation of the meeting of the Standing 
Committee on Plants, Animals, Food and Feed - Section Phytopharmaceuticals, Pesticide Residues 
(SC PAFF), held on 26 -27 September 2022. A summary of the discussion can be found in the report 
of the meeting.6 The d raft Regulation was endorsed by the member States and will be submitted to 
the Council and the European Parliament for scrutiny. If no objection is raised, adoption by the 
Commission is foreseen for early 2023. It will become applicable in 2026 to allow op erators in non -
EU countries to adapt to the new rules. The EU would like to thank the different countries once again 
for providing comments on this draft and hopes to provide soon responses that sufficiently clarify 
the points raised.  
2.51.   The representative of  the United States  provided the following statement. The United States 
respectfully questions the content of the EU's statement especially considering the large number of 
Members who have raised concerns with this measure. To my count there were more than 18 
Members raising concerns today. In its response the EU noted that it was still carefully studying 
 
6 https://food.ec.europa.eu/system/files/2022 -10/sc_phyto_20220926_ppr_sum_0.pdf   G/TBT/M/88  
 
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  Members' comments. However, the SC PAFF Committee and member States have already moved 
forward in approving this measure, within weeks of receiving WTO Mem bers' comments that were 
due on 4 September. The SC PAFF Committee report itself that was shared with us notes various 
WTO Members, EU member States and a plethora of industry members submit comments on this 
measure. How could this volume of comments have been taken into account in such a short period 
of time? While the report and the EU note that these were provided well in advance of the SC PAFF 
Committee meeting, it is unclear how long SC PAFF had to consider these comments, nor what topics 
were consider ed during their discussions. Since the measure is currently with the EU Commission, 
we would ask that the EU confirm that WTO Member comments will be taken into account by the 
Commission prior to its finalization. Further, have Member comments been shared with the EU 
Commission?  
2.52.   The representative of the European Union  provided the following statement. As I said, the 
comments have been taken into account and for the replies we are still having inter -service 
consulations and the Commission is going to take p osition on the basis of the comments we received.  
2.1.3.3   United States - Protection of Stratospheric Ozone: Listing of Substitutes Under 
the Significant New Alternatives Policy Program in Refrigeration, Air Conditioning, and 
Fire Suppression, G/TBT/N/USA/1907  (ID 7647) 
2.53.   The representative of China  provided the following statement. According to the "Markings " 
section of the draft regulation (pages 45538 , 45540 , 45542 , 45544 , 45546 , 45548 , 45552 , 45554 , 
45555 , 45557 , 45558), refrigeration equipment is required to have disti nguishing red -colour -marked 
service ports, pipes, hoses, and other devices, to indicate the use of a flammable refrigerant. We 
believe that the red marking requirement will increase manufacturing costs in production, which is 
not required in the given test ing standard UL 60335 -2-40. According to Article 2.2 of the TBT 
Agreement, "Members shall ensure that technical regulations are not prepared, adopted or applied 
with a view to or with the effect of creating unnecessary obstacles to international trade ", we suggest 
that red markings be replaced with red labelling so that enterprises could provide required 
information through labelling without change of the production process. In addition, in order to 
ensure the consistency between regulations and supporting standards, it is suggested that the US 
modify the adopted test standard UL 60335 -2-40, adding the requirement of red labelling for 
flammable refrigerants to the standard.  
2.54.   In response, the representative of the United States  provided the following statement . The 
United States thanks China for its interest in the Environmental Protection Agency's proposed rule, 
"Protection of Stratospheric Ozone: Listing of Substitutes Under the Significant New Alternatives 
Policy Program in Refrigeration, Air Conditioning, a nd Fire Suppression. " Thank you for submitting 
your comments in writing to the United States Enquiry Point on 13 September 2022. The Enquiry 
Point acknowledged your submission. Those comments were submitted to the U.S. Environmental 
Protection Agency, whic h is currently considering comments on the proposed rule. Any final rule 
from the proposal will be published, and EPA will respond as appropriate to substantive comments 
from stakeholders in any final decision.  
2.1.3.4   India - Public Consultation for declaring two  or more prime constituents of the 
commodity on the front side of the package/Revision of Legal Metrology (Packaged 
Commodities Rules), 2011 (ID 7658) 
2.55.   The representative of the United States  provided the following statement. On 16 August 2022, 
the Department of Consumer Affairs, Legal Metrology Division, circulated a public consultation, 
titled: I -19//42/2022 -W&M, "Inviting Public Consultation for declaring two or more prime 
constituents of t he commodity on front side of the package with the Brand Name/ Logo, " which 
proposed to amend the Legal Metrology (Packaged Commodities Rules), 2011. According to the 
notice, the Department provided until 31 August 2022 (15 days) for interested stakeholder s to 
provide input. The United States requested notification of the draft amendments on 9 September 
2022. We have not yet heard a response to our request for notification from India. Our industry 
stakeholders provided comment to the consultation through In dia's domestic process on 31 August 
2022. The United States has questions regarding the proposed amendment to India's Legal 
Metrology (Packaged Commodities) Rules, 2011 that requires new labelling requirements for 
 
7 For previous statements follow the thread under ID 764 . 
8 For previous statements follow the thread under ID 765 . G/TBT/M/88  
 
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  packaged products that contain two or more  prime constituents. According to industry, the 
amendment could change the labelling requirements for many consumer products, including 
cosmetics. We understand that India's Department of Consumer Affairs published the proposed 
amendment for a 15 -day consu ltation in August, however the amendment has not yet been notified 
to the WTO. We ask India to notify the draft proposed amendment to this Committee; provide at 
least a 60 -day comment period; and take any comments received into account before finalizing an d 
adopting the measure. Notably, the proposed text of Rule 6(1)(ba) requires front of pack labelling 
to list the "prime constituents " of a product as well as information as to the product's "unique selling 
point" and "unique selling proposition ". Will Indi a provide definitions for these terms? Can India 
confirm which products the proposed amendment would apply to, and specifically, whether the new 
labelling requirements would apply to cosmetics. If the proposed amendment applies to cosmetics, 
we note the me asure may be duplicative of – or even in conflict with – existing requirements for 
ingredient labelling and claims in India's Drugs & Cosmetics Act, 1940, which is currently in revision, 
and India's Cosmetics Rules 2020. We support the overall objective of  the amendment, but we are 
concerned that could be more trade restrictive than necessary, while not providing additional value 
to consumers. We thank India for consideration of these comments.  
2.56.   In response, the representative of India provided the following  statement. India has taken 
note of the concern of the USA regarding of Legal Metrology (Packaged Commodities Rules), 2011 
and thanks the USA for its interest in this matter. The concerned raised has been shared with capital 
and is being examined.  
2.1.3.5   European  Union - Draft Commission implementing regulation laying down rules 
for the application of Regulation (EU) 2019/2144 of the European Parliament and the 
Council as regards uniform procedures and technical specifications for the type -approval 
of fully automa ted motor vehicles with regard to their automated driving system (ADS), 
G/TBT/N/EU/884  (ID 7669) 
2.57.   The representative of China  provided the following statement. Annex 2, part 7.1.1 hasn't 
provided a method to clearly define the acceptance criteria for safety. Is the "acceptance criter ia" a 
specific numerical value? If it is, the regulation clearly says that the determination of "acceptance 
criteria " highly depends on the relevant parameters regarding the accident data, manually driven 
vehicle performance data, etc. of the actual transp ort scenario in the EU member States, but the 
regulation hasn't indicated the ways for the manufacturers to obtain those essential data. The 
manufacturers are not able to understand how to satisfy the requirement. As the regulation is 
officially published,  it is suggested that the EU follow the transparency and national treatment 
principles of the TBT Agreement and issue additional implementation guidelines to: (i) define the 
term of "acceptance criteria " , and if it is a specific numerical value, provide t he calculation formula 
and the meanings of each parameter; (ii) and to provide non -EU members  with the channels to fairly 
obtain the relevant necessary information about accident data, performance data of the manually 
driven vehicle, etc. of all the EU member States. In the case a of 1.3.2 in Part 1 of Annex III, the 
speed directions of the self -vehicle and target vehicle are different. The formula hasn't specified 
whether Ve and Va are vectors or absolute values, which may lead to different calculation methods 
between the manufacturer and the Type Approval Authority and thus different calculation results, 
eventually causing unnecessary obstacles for enterprises to carry out product type approval. It is 
suggested that the EU clarify whether Ve and Va are vectors or absolute values, and further explain 
the physical significance of the formula. 5.8 of  Annex 3, Appendix 1 Part 2 "Certificate of Compliance 
for Safety Management System " describes how to apply for SMS certificate but doesn't define the 
requirements that SMS shall comply with, which may make manufacturers unable to find any steps 
to start w ith and limits to follow, and lead to inconsistent adoption of evaluation standards among 
different Type Approval Authorities. It is suggested that the EU add detailed technical requirements 
and reference standards for SMS.  
2.58.   In response, the representative of the European Union  provided the following statement. 
Thank you to the delegation of China for their comments on the Commission implementing regulation 
laying down rules for the application of Regulation (EU) 2019/2144 of the European Parliament and 
the Council as regards uniform procedures and technical specifications for the type -approval of fully 
automated motor vehicles with regard to their automated driving system (ADS). The EU has carefully 
studied the comments provided by China and feels that these  were addressed in the final act. 
Commission implementing Regulation (EU) 2022/1426 of 5 August 2022 laying down rules for the 
 
9 For previous statements follow the thread under ID 766 . G/TBT/M/88  
 
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  application of Regulation (EU) 2019/2144 of the European Parliament and of the Council as regards 
uniform procedures and technica l specifications for the type -approval of the automated driving 
system (ADS) of fully automated vehicles as published in the EU official journal on 26 August 2022, 
reflects to the most practical extent the comments provide by China and other stakeholders. 
However, to reassure China, in addition, the European Commission maintains a dialogue with 
stakeholders in the Motor Vehicle Working Group - subgroup on Automated and Connected Vehicles 
where an interpretation document on the implementation of Regulation ( EU) 2022/1426 is being 
discussed and prepared. This document is expected to provide the necessary guidelines to 
manufacturers on how to apply certain provisions of the Regulation. It is planned to finalise the 
document by the end of this year and make it p ublicly available. The EU would like to thank the 
Chinese authorities once again for providing comments on the notified draft.  
2.1.3.6   Australia - Water Efficiency Standard AS/NZS 6400:2016, G/TBT/N/AUS/142  (ID 
76710) 
2.59.   The representative of China  provided the following statement. According to the draft standard, 
in terms of water efficiency requirements, the classification of dishwashers in Australia is based on 
the number of sets of applicable tableware, which is divided into two categories: dishwashers 
suitable for nine sets of tableware o r more and those suitable for less than nine sets of tableware. 
Currently, the popularity of small dishwashers is increasing due to their ease of operation, small 
space requirement, and low water consumption, and they are gradually becoming a global trend in 
household purchases, among which are sink dishwashers. China believes that the existing 
classification of dishwashers in Australia in terms of water efficiency requirements may lead to 
unrepresentative water efficiency test results, thereby constraining  the development of the small 
dishwasher industry. In addition, IEC 60436 singles out small dishwashers with six sets of dishes for 
which a performance test method has been developed. In order to better regulate small dishwashers 
on the market and avoid un necessary obstacles to trade, we suggest Australia develop separate 
water efficiency star requirements for small dishwashers and set separate water efficiency star 
requirements for dishwashers with six sets of dishes or less.  
2.60.   In response, the representativ e of Australia  provided the following statement. Australia thanks 
China for raising their concerns with Australia on the Water Efficiency Standard AS/NZ 6400:2016 
and the Water Efficiency Labelling and Standards (WELS) Scheme. Australia notified the WTO TB T 
Committee on 3 June 2022 with document G/TBT/N/AUS/142  with the WELS Scheme rating and 
labelling amendment. Members were provided with 60 days to provide comments to Australia's TBT 
Enquiry Point. While the date of adoption was listed as 30 June 2022, Australia still welcomed 
comments beyond this date with entry into force of the amendments on 1 July 2023. The scheme 
reduces demand for potable water by informing consumers about the water efficiency of household 
products, including taps, showers, toilets, urinals, washing machines and dishwashers at the point 
of sale. WELS helps businesses and consumers to make decisions that can reduce their water use, 
saving them money on water and energy bills while improving national water security and reliability 
across Australia. We thank Chin a for outlining their concerns regarding the impact of the WELS 
scheme on dishwasher products. Australia notes there are 71 products of smaller capacity 
dishwashers, which range in size from three – eight place settings, registered under the scheme. 
They h ave all demonstrated a water efficiency of 2.5 stars or more and meet the minimum water 
efficiency requirement for dishwashers with less than nine place settings. We would encourage 
makers of the sink dishwasher to register their products in Australia if t hey intend to supply them 
to the Australian market. In relation to IEC 60436, we note Australian standard AS/NZ 2007 does 
refer to this international standard for further guidance on place settings for electric dishwashers for 
household use. Australia welc omes further dialogue and engagement with China on water efficiency 
standards and the WELS Scheme.  
2.1.3.7   European Union - Draft Commission Regulation laying down ecodesign 
requirements for mobile phones, cordless phones and slate tablets pursuant to Directive 
2009/125/EC of the European Parliament and of the Council, G/TBT/N/EU/918  (ID 
76811) 
2.61.   The representative of the Republic of Korea  provided the following statement. The Republic 
of Korea appreciates this opportunity to make comments regarding the EU's "Draft Commission 
 
10 For previous statements follow the thread under ID 767 . 
11 For previous stateme nts follow the thread under ID 768 . G/TBT/M/88  
 
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  Regulation laying down eco -design requirements for mobile phones, cordless phones and tablets" 
(hereinafter, the Draft Regulation) notified to the WTO on 1 September 2022 as G/TBT/N/EU/918  
and coming into effect in January 2024. Some of the articles in the Draft Regulation may hinder the 
introduction of innovative technologies and restrict the consumer's right to choose the latest 
products and services, by setting criteria that are excessive compared to other eco -design 
regulations currently in effect for other household appliances such as TVs and refr igerators. So the 
Korean government would like to convey the following requests to the EU: first, the reliability of the 
foldable display cannot be guaranteed if the foldable display mechanism is provided as separated 
spare parts (e.g. Mechanical display f olding mechanism, Protective foil for foldable displays, etc.). 
So Korea requests that the EU either change the spare parts requirements so that "Mechanical 
display folding mechanism", "Protective foil for foldable displays" and "Foldable display" can be 
supplied as one "assembly form", or provide a grace period for more than two years for technology 
development.  
2.62.   Second, with the latest trend for smartphone/tablet designs, the batteries are fixed or 
integrated into the devices with adhesive tapes, so it is impossible to satisfy the strengthened 
disassembly requirements that require manufacturers, from 18 months after the Regulation's entry 
into force, to ensure batteries can be replaced (i) by a layman, (ii) in a use environment, ( iii) using 
basic tools, (iv ) and with fasteners being reusable. Therefore, Korea requests that the EU ease the 
Draft Regulation to an extent so that battery replacement can be carried out (i) by a generalist, 
(ii) in a workshop environment, (iii) using commercially available tools, (iv) and with fasteners being 
removable or reusable. Third, the Draft Regulation stipulates waterproof/dust -grade of IP67 as one 
of the exception conditions to the requirements of battery replacement and battery availability to 
end-users as spare parts. Ho wever, foldable smartphones (the latest form factor of mobile phones) 
are impossible to satisfy the dust tight level as required in the Draft due to technical issues. For this 
reason, Korea requests to subdivide the exception criteria into two (such as IP4 X for foldable types, 
IP6X for the other types, etc.) or add a condition that exempts the waterproof/dustproof rating 
requirements for foldables.  
2.63.   Fourth, the common usage scenario of foldable smartphones has not been appropriately taken 
into account in the  test criteria on resistance to accidental drops. Since foldable smartphones are 
typically used single -handed when folded and double -handed when unfolded, Korea requests the EU 
to subdivide the test criteria into 100 falls as folded and 10 falls as unfolde d. Fifth, delivery of spare 
parts within five days is overly burdensome because delivery time is highly affected by the 
transportation circumstances of each country in the EU territories. Since other eco -design regulations 
stipulate the delivery period of spare parts as 15 days, Korea requests to (i) allow the delivery time 
of "within 15 days" in the case of mobile devices as well and (ii) also add a clause waiving the 
obligation in special circumstances caused by external factors such as natural disasters or wars, etc. 
Lastly, due to the Draft's requirements to provide functionality updates and security updates to the 
Operating System in relatively short periods of time (which are within four months and two months 
respectively, after the public release of t he source code) and the requirement to provide an OS 
Rollback option, Korean device manufacturers that outsource the OS software for their smartphone 
products are concerned that the security and stability of the product might be compromised. So 
Korea reque sts that the EU delete the time restrictions for security & functionality S/W updates and 
the OS Rollback option requirement clause.  
2.64.   In response, the representative of the European Union  provided the following statement. 
Thank you to the delegation of the Republic of Korea for their diligent comments on the draft 
Ecodesign measures for mobile phones, cordless phones and slate tablets pursuant to Directive 
2009/125/EC of the European Parliament and of the Council. Let me reassure the Delegation of the 
Republ ic of Korea that the European Commission is analysing Korea's concerns carefully, and in 
particular the potential issues related to the new and innovative category of foldable and flexible 
displays. Unfortunately, the EU is not yet in a position to give ex tensive substantive feedback on the 
concerns that were voiced here today. The European Commission is currently consulting the EU 
member States on the draft measures and the comments that we received in the context of the TBT 
consultation. Once that is over , we will be able to provide more detailed feedback. However, please 
note that we are committed to ensure that new product designs will not be hampered by the potential 
Ecodesign requirements, while at the same time addressing legitimate concerns regarding  the 
durability of products and of their components.  G/TBT/M/88  
 
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  2.1.3.8   Viet Nam - Draft of National technical regulation on the restriction of the use of 
certain hazardous substances in electrical and electronic equipment, G/TBT/N/VNM/236  
(ID 76912) 
2.65.   The representative of Japan  provided the following  statement. Japan appreciates the 
reference from Viet Nam prior to today's Committee meeting. However, we have serious concerns 
on this issue. Therefore, we would like to raise this as an STC. Japan shares the following concerns 
regarding the draft of the National technical regulation on the restriction of the use of certain 
hazardous substances in electrical and electronic equipment (EEE). This draft technical regulation 
(hereinafter referred to as the "draft TR ") requires restrictions on certain hazardous  substances in 
EEEs, and sets thresholds for each homogeneous material. Although the conformity assessment 
procedures in the draft TR require analytical testing of specific samples, EEEs are complex products, 
with tens to hundreds of thousands of homogeneo us materials contained in one EEE. Therefore, 
assessing conformity based on the analytical testing of those huge numbers of homogeneous 
materials requires a significant workload and cost, and is not feasible for both the conformity 
assessment body and EEE manufacturers. EEEs are also composed of a lot of parts and materials 
from a variety of suppliers around the world, including Viet Nam. If such analytical testing is carried 
out, it will only confirm a specific sample at a given time. Therefore, in order t o ensure compliance 
with the laws and regulations on chemical substances contained in EEEs, where parts and materials 
are constantly changed, it is essential to have a systematic conformity assessment procedure based 
on the international standard IEC 63000 , which receives information on chemical substances 
contained from upstream suppliers, prepares and updates technical documents in response to 
changes in parts and materials, and assesses conformity through a self -declaration of conformity. 
We therefore re quest that Vietnam accept the self -declaration of conformity by EEE manufacturers 
in accordance with IEC 63000, as well as EU RoHS Directive (2011/65/EU) and RoHS type regulations 
in other countries and regions, as both are already in force and operational  and are listed as 
references in this draft TR.  
2.66.   We understand that CR marking is currently used for safety and EMC certification in Vietnam. 
The approach of applying CR marking to products that comply with the draft TR is similar to the 
approach of CE mark ing in the EU. However, in EU RoHS, CE marking is applied on the basis of a 
self-declaration of conformity by the manufacturers, as mentioned above. Therefore, the 
requirement on marking in the draft TR of Viet Nam should be based on a self -declaration of 
conformity by the manufacturers, as well as in EU RoHS. Appendix 1 of the draft TR shows the names 
of the products covered by the draft TR and the 4 -digit HS codes corresponding to the covered 
product names. However, the covered product name and a 4 -digit HS code do not necessarily match 
the scope of the product defined by each. For example, in STT "VIII -1" of Appendix 1, HS code 9022 
is described corresponding to the covered product name "radiation therapy equipment," but HS code 
9022 is not consistent wit h the covered product name "radiation therapy equipment" because HS 
code 9022 includes all X -ray equipment. Similarly, HS code 8423 in STT "IX -4" is not consistent with 
the covered product name "Measuring, weighing or adjusting apparatus for household or l aboratory 
use." Therefore, Japan would like to request that the product be designated by the name of the 
covered product or a 6 -digit or higher HS code, not by the 4 -digit HS code, so that the scope of the 
draft TR is clear and not expanded beyond what is necessary. Regulating large -scale stationary 
industrial tools, large -scale fixed installations and photovoltaic panels is considered to be more trade 
restrictive than necessary for the purpose of protecting human health or safety, in view of the fact 
that these products are not regulated under the EU RoHS and the RoHS type regulations in other 
countries and regions. For example, printers that fall under HS code 8443 should be exempt from 
the regulations if the printer is a large fixed installation. Therefor e, Japan would like to request these 
products be listed on Table 1 of Appendix 2 that lists products not covered by this regulation.  
2.67.   Appendix 3 contains a list of applications exempted from the draft TR, but it does not include 
many applications that are e xempted from the EU RoHS Directive and the RoHS type regulations in 
other countries and regions. The applications excluded from the EU RoHS Directive are those that 
cannot be replaced by current science and technology, and if these applications were subjec t to 
regulation, the function of EEEs would not be possible. Therefore, Japan would like to request that 
all of the applications exempted from the EU RoHS Directive be listed in Appendix 3, and exempted 
from the draft TR. To ensure that the above concerns are addressed, Japan would like to require 
that this technical regulation be harmonized with international standards and practices, and that the 
 
12 For previous statements follow the thread under ID 769 . G/TBT/M/88  
 
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  operation under the technical regulation be quickly clarified to be no more trade -restrictive than 
necessary to  fulfil its legitimate objectives.  
2.68.   In response, the representative of Viet Nam  provided the following statement. Vietnam would 
like to thank Japan for interest in our draft measure. On 29 August 2022, Vietnam notified "Draft 
National Technical Regulation o n the Restriction of the Use of Certain Hazardous Substances in 
Electrical and Electronic Equipment" in Notification G/TBT/N/VNM/236 . Vietnam received comments 
from Members and interested stakeholders. After careful consideration of all comments, Vietnam 
has recently decided to can cel the promulgation of this draft technical regulation.  
2.1.3.9   United Kingdom - Designated notice and Designated vendor direction (ID 77013) 
2.69.   The representative of China  provided the following statement. On 13 October 2022, the UK 
Government released the final ve rsion of the Designated notice and the Designated vendor direction. 
These two measures discriminate against Chinese enterprises and products, which violates Articles 
2.1, 2.2 of the TBT Agreement, create unnecessary trade barriers and have great negative i mpacts 
on telecommunication trade and industry. Designated vendor direction requires that after the date 
this Direction comes into force, not to use any Huawei equipment in its 5G networks if such 
equipment is procured after 31 December 2020, and not to in stall any Huawei equipment in any 
fixed fibre access network if the manufacturing process or supply chain for such equipment has been 
altered by changes to the United States Foreign -Produced Direct Product Rule; that after 28 January 
2023, not to use Huawe i equipment or any services delivered by or on behalf of Huawei in mobile 
networks of locations significant to national security; that after 31 October 2023, not to allow a 35% 
market share for Huawei equipment in FTTP networks, and other gigabit and highe r capable access 
networks; that after 31 December 2023, not to use Huawei equipment or any services delivered by, 
or on behalf of, Huawei in the execution of its Core Network Functions; and that after 31 December 
2027, not to use Huawei equipment or any se rvices delivered by, or on behalf of, Huawei in any part 
of its 5G networks. We believe these two documents violate the NT and MFN non -discrimination 
principle of the WTO and affect free trade in the field of communications. We urge the UK to revise 
them i n the right direction.  
2.70.   In response, the representative of the United Kingdom  provided the following statement. The 
United Kingdom thanks China for their interest in the Designated notice and Designated Vendor 
Direction. Unfortunately, we have not received any information on China's concerns in advance of 
today and were not given any opportunity to engage beforehand, as per Geneva TBT practice. In 
this context, we are unable to provide a substantive response at this time but look forward to 
receiving further  information on China's concern and we remain ready to respond.  
2.1.3.10   United States - Energy Conservation Program: Energy Conservation Standards 
for Ceiling Fans, G/TBT/N/USA/861/Add.8  (ID 77114) 
2.71.   The representative of China  provided the following statement. In accordance with Table II.1, 
the minimum efficacy corresponding to the range larger than equal to 120 lumina is calculated to be 
44.63 lm/w (74.0 –29.42*0.9983 lm/w). The minimum efficacy corresponding to the range of fe wer 
than 120 lumina is 50 lm/w. There is a big difference between the two, which will cause trouble for 
products with luminous flux close to 120 lumina. It is suggested that the US reconsider whether the 
computing method of minimum efficiency is reasonable  and give a solid scientific basis for the 
method.  
2.72.   In response, the representative of the United States  provided the following statement. United 
States thanks China for bringing to the United States attention your concerns about this draft 
regulation. The United States has not received any written comments from China through the US 
Technical Barriers to Tra de Enquiry Point, nor has the United States received any comments from 
China in the US Federal Register Docket or Regulations.gov . If China replies to the notification with 
comments by the deadline, the United States responds to all comments publicly when issuing the 
final rule. In addition, having written comments in advance of the WTO TBT Committee aids other 
Members' understanding of what the trade concerns or questions might be. China repeatedly raised 
US Department of Energy rules on the TBT Committee agenda, and has seldom provided a comment 
 
13 For previous statements follow the thread under ID 770 . 
14 For previous statements follow the thread under ID 771 . G/TBT/M/88  
 
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  for us to address in the rulemaking process. This seems like a false opportunity to raise an issue 
against the United States in this forum.  
2.1.3.11   Argentina - Decree Implementing Law No. 27.642 on the Promotion of Healthy  
Eating, G/TBT/N/ARG/435 ; G/TBT/N/ARG/43 5/Add.1  (ID 77215) 
2.73.   The representative of the United States  provided the following statement. The United States 
supports Argentina's public health objectives of reducing diet -related non -communicable diseases. 
Argentina published its final Front -of-Pack Nut rition Labelling Law, entitled Decree implementing 
Law No. 27.642, on 23 March 2022, and notified the measure to the WTO nine days later, on 1 April 
2022. The United States reiterates the importance of notifying measures to the TBT Committee with 
at least a 60-day comment period so that interested parties have an opportunity to submit written 
comments, discuss these comments upon request, and have comments considered by Argentina 
before finalizing measures. We understand companies were expected to comply wi th the new law 
by September 2022, just six months after publication of the final law. Can Argentina confirm whether 
the law is being fully implemented at this time? The United States is concerned about the short 
implementation period of this measure. We un derstand that Argentina is considering extensions to 
the implementation period in specific cases. We request that Argentina consider a 24 -month 
implementation period for stage one, until March 2024, to allow sufficient time for industry to 
effectively comp ly. Other countries in the region have adopted a 24 -month period when 
implementing similar labelling policies.  
2.74.   We note that other countries have permitted stickering of labels to provide greater flexibility. 
Will Argentina consider temporary stickering as an option for compliance during the implementation 
period? What flexibilities will Argentina provide for label placement to accommodate different sized 
packaging? The labels may account for a disproportionate surface area on the packaging of smaller, 
individually packaged items. Has Argentina considered that the Pan -American Health Organization's 
Nutrient Profile was based on the World Health Organization's nutrient intake goals intended for total 
diets, rather than profiles more appropriate for individual foods making up total dietary patterns? 
We raised many of these concerns during our July TBT Committee bilateral meeting and Argentina 
responded that their Ministry of Health would provide a response. We are still awaiting a response 
from Argentina.  
2.75.   The representative  of Guatemala  provided the following statement. We recognise Argentina's 
right to protect the health of its population and to provide food information to the consumer. Article 
2.2 of the Agreement on Technical Barriers to Trade provides that Me mbers shall ensure that 
technical regulations are not prepared, adopted or applied with a view to or with the effect of creating 
unnecessary obstacles to international trade and shall not be more trade -restrictive than necessary 
to fulfil a legitimate obje ctive. Article 2.9 states that whenever a relevant international standard 
does not exist or the technical content of a proposed technical regulation is not in accordance with 
the technical content of relevant international standards, and if the technical r egulation may have a 
significant effect on trade of other Members, Members shall publish a notice in a publication at an 
early appropriate stage, in such a manner as to enable other Members to become acquainted with 
it, and shall allow reasonable time for other Members to make comments in writing, discuss these 
comments upon request, and take these written comments and the results of these discussions into 
account. In the case of the two notifications, which address separate technical regulations, Argentina  
failed to comply with the principle of transparency established by that Agreement, since the 
notifications were submitted when the texts had already been formally approved by its government, 
and Members were not given the opportunity to comment on them at  an early stage, prior to their 
final formulation.  
2.76.   In response, the representative of Argentina  provided the following statement. We would first 
like to point out that Law No. 27.642 on the Promotion of Healthy Eating is designed to ensure the 
population's  right to health and adequate food, through the promotion of healthy eating, by providing 
simple and comprehensible nutritional information for packaged foods and non -alcoholic beverages. 
This will promote confident and active decision -making and warn cons umers about high levels of 
sugars, sodium, saturated fats, total fats and calories, using clear, appropriate and accurate 
information that protects consumer rights, which is the key focus of the law. Under no circumstances 
can Law No. 27.462 be considered a barrier to trade, as it merely seeks to give people simple and 
easily understandable nutritional information about the products covered by the Law. Nevertheless, 
 
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  it should be noted that the Agreement on Technical Barriers to Trade recognizes that countri es may 
put in place measures designed to protect public health. This is recognized in the preamble to and 
in Article  2.2 of the Agreement. Law No. 27.642 was enacted at the end of an extensive democratic 
process, with wide -ranging discussions in both chamb ers of the National Congress, where 
representatives of industry, academia and civil society had the opportunity to put forward their 
positions. Parliamentary decisions were made during the discussions in the committees, in which a 
huge amount of relevant s cientific evidence was disseminated. Similarly, various sectors were 
involved in the process of drawing up the implementing Decree. These sectors were given the 
opportunity to submit proposals and suggestions, which were included to the extent permitted by  
law. 
2.77.   With respect to the United States’ concern about the time frames for implementing the 
measure, Law No. 27.642 has a number of implementation phases both for the nutrient profile 
system, and for large corporations and SMEs (which have different deadli nes). In addition, the Law 
also included an option to request a single six -month extension for the first implementation phase. 
Deadlines for large corporations: 20 July 2022: deadline for requesting extensions; 20 August 2022: 
deadline for implementing the  first phase / start of the second phase; 16 February 2023: end of the 
approved extension period for the first phase; 20 May 2023: deadline for implementing the second 
phase; and 20 May 2024: deadline for approved special cases involving returnable contain ers. 
Deadlines for SMEs: Tier one micro -, small and medium -sized companies under Law No. 25.300 
(MSMES), as well as cooperatives operating in the popular economy and suppliers of products in the 
family farming sector, as defined in Article 5 of Law No. 27. 118. 20 January 2023: deadline for 
requesting extensions; 20 February 2023: deadline for implementing the first phase / start of the 
second phase; 19 August 2023: end of the approved extension period for the first phase; 20 May 
2023: deadline for implement ing the second phase; and 20 May 2024: deadline for approved special 
cases involving returnable containers.  
2.78.   Therefore, it is expected that, by November 2023 (two years after the Chamber of Deputies 
approved the Law), all products covered by the regulations  and produced from that date will have 
to comply with front -of-pack labelling requirements, irrespective of the production capacity of the 
company producing them. With respect to placing adhesive labels on packages to provide greater 
flexibility, national legislation (the Argentine Food Code) provides that, in the case of imported 
products, self -adhesive labels may be added to adapt the labelling to the regulations in force in the 
country. In the case of returnable containers with lithographed and/or painte d labels, it shall be 
permitted to add the corresponding warning signs or messages in the form of firmly affixed, heat -
seal or heat shrink labels. This will only be permitted for up to 30 months after the Law enters into 
force, meaning that, from 20 May 20 24, the front -of-pack nutritional labelling must be lithographed 
and/or painted onto all returnable containers.  
2.79.   With respect to placing labels on packages of different sizes, the size of the label is defined 
by law: Article 5 states that "the size of each label shall never be less than five percent (5%) of the 
surface area of the front of the package", with "the front of the package" meaning the part of the 
label featuring the sales description and the brand or logo, if any, most prominently. Therefore, 
Appendix  II to implementing Decree No. 151/2022 established more than 15 size ratio categories, 
in order to ensure that small packages comply with the 5% legal requirement. The regulations 
provide that micro -labels, which cover 15% of the surface area of the front of the packages, can 
only be affixed to packages with a surface area of less than 10 cm2. For product packages with a 
front surface area between 10  cm2 and 20  cm2, it was deemed that each warning label should cover 
5% of the surface area. For package s with a surface area greater than 20 cm2 and for products that 
have more than one label, the implementation handbook proposes an adjustment whereby the 
"surface area available for labels" is calculated, which is set at 65% of the surface area of the front  
of the package. Packages bearing a single label, irrespective of their size, must use the label sizes 
set out in Tables 1 and 2 of the implementing Decree. Moreover, when the surface area of the front 
of the package is greater than 300 cm2, the only size of octagonal warning label to be used is 3.9 
cm x 3.9 cm, while for rectangular warning labels it is 6.4  cm x 1.6 cm.  
2.80.   It was decided to apply the correction factor of 0.65 to products with a front of package 
surface area greater than 20 cm2, but not to pro ducts where it is between 10 cm2 and 20  cm2, 
because applying this factor would result in a front -of-pack surface area of less than 10  cm2 for this 
size category. This could contravene Article  5 of the Law, which clearly states that "should the 
surface are a of the front of the package be less than or equal to 10 centimetres squared and should 
it bear more than one label, the enforcement authority shall determine the suitable position of the G/TBT/M/88  
 
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  labels". With respect to the Nutrients Profile, we must first point  out that the nutrient profiling system 
(NPS) of the Pan American Health Organization (PAHO) is based on the World Health Organization 
(WHO) nutrient intake goals for the nutrients assessed. The Food Guidelines for the Argentine 
Population (GAPA) are based  on the same international recommendations which state that the 
nutrient profile models need to complement and support food -based dietary guidelines in the region 
in which they are applied. Therefore, the Argentine Ministry of Health carried out a study wh ich 
evaluated the degree of concordance between eight NPSs used under different regulations 
(PAHO/WHO, Uruguay, Chile, Peru, Ecuador, Bolivia, the United Kingdom and the NPS proposed by 
the Food Industry Coordination Committee (COPAL)) with the national re commendations made in 
the GAPA. The PAHO NPS had the highest overall degree of concordance (almost 80%) in the 
complete concordance evaluation and, when carrying out an overall evaluation of each NPS, the 
PAHO model performed the best, corresponding to the  national scientific evidence available to date. 
This suggests that this nutrient profile is the best option for assessing the food sold in our country. 
Moreover, Law No. 27.642, which is the product of a wide -ranging legislative discussion, with the 
participation of all sectors involved, clearly states that the Nutrient Profile Model of the Pan American 
Health Organization shall be used, without any possibility of changing this.  
2.81.   To conclude, we would like to reiterate that preventing malnutrition includes,  among other 
measures, providing warnings about high levels of critical nutrients, such as sugars, sodium, 
saturated fats, total fats and calories, in packaged foods and non -alcoholic beverages, using clear, 
appropriate and accurate information that protec ts consumer rights, which is the key focus of Law 
No. 27.642 on the Promotion of Healthy Eating.  
2.1.3.12   Spain - Barcelona labelling classification requirements for squid (ID 77316) 
2.82.   The representative of China  provided the following statement. Squid exported from China is 
mixed in terms of breeds, usually consisting of three breeds that are extremely similar in appearance 
and taste, weighing 6 -8 grams individually. At present, even extremely skilled fishermen can hardly 
distinguish them by the naked eye, and neithe r can machine sort them out automatically. 
Furthermore, it is not reasonable and feasible to check DNA for classification. We suggest Spain re -
evaluate the rationality of the classification of squid labels, develop testing methods and standards 
that are co mpatible, and remove the existing classification requirements until reasonable standards 
are set.  
2.83.   In response, the representative of the European Union  provided the following statement. 
Indeed, as China explained, the Spanish authorities have rejected the entering of several containers 
of squid from China during border health checks. The reason for this decision is the non -compliances 
and divergences found between the species declared in the required documentation for customs 
clearance, including the respec tive health certificate; and the outcome of the checks carried out at 
the EU border by the authorities of the EU member States in accordance with the provisions of EU 
regulations. These sanitary controls carried out at the Spanish Border Control Posts on p roducts of 
animal origin, such as squid, have their legal basis in existing EU legislation: - Regulation (EC) 
178/2002 laying down the general principles and requirements of food law, establishing the 
European Food Safety Authority and laying down procedur es in matters of food safety. 
(G/SPS/N/EEC/110)  - Regulation (EU) 2017/625 on controls and other official activities performed 
to ensure the application of food and feed law, animal health and welfare, plant health and plant 
protection rules. ( G/SPS/N/EU/43)  - Implementing Regulations (EU) 2020/2235 and 2019/2130, 
which regulate the documentation, identity and physical checks to which these products must be 
subjected. ( G/SPS/N/EU/345)  
2.84.   One of the objectives of these controls, prescribed in the previously mentioned legislation, is 
to verify that the pr oducts inspected correspond to what is declared in the official certificates and 
other accompanying documentation, including verification of the species, and may require the need 
to use laboratory tests to determine the correct species of the product. If t here are discrepancies on 
this and other none -compliances, the introduction into the territory of the Union cannot be accepted. 
Consequently, the Spanish authorities have proceeded in accordance with EU legislation regarding 
to border controls and requirem ents to be met by products of animal origin intended to be introduced 
into the EU customs territory. Spain does not have specific legislation on these matters. This is why 
 
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  it has not been possible to notify any text to the WTO, nor is there any publication  in the Spanish 
Official State Gazette (Boletín Oficial del Estado), as requested by the Chinese authorities.  
2.1.3.13   India - Safety requirements with respect to the Rechargeable Electrical Energy 
Storage System (REESS) for electric power train vehicles, of AIS -038 and AIS -156 (ID 
77417) 
2.85.   The representative of the Republic of Korea  provided the following statement. The Republic 
of Korea appreciates this opportunity to make comments on India's amended "AIS -038 and AIS -
156, Safety requirements with respect to the Rech argeable Electrical Energy Storage System 
(REESS) for electric power train vehicles," which were announced on 27 September 2022 through 
the website of the Ministry of Road Transport and Highways and will be implemented in phases from 
1 December this year. The Indian Automotive Industry Standards AIS -038 and AIS -156 (hereinafter, 
the Automotive Standards) stipulate specific requirements applied to (L, M, N category) vehicles 
using electric powertrains, and Korean companies are endeavouring to comply with the  Automotive 
Standards of India. However, the companies have raised concerns about the difficulties in complying 
with some of the requirements amended in September as they are excessive compared to the 
relevant international standards. Thus, Korea would lik e to make the following comments: first, 
requirements regarding "temperature sensors", "audio -visual alarm", "active paralleling circuits", 
and "cell -to-cell spacing distance", specified in Annex 8K of AIS -156 and Annexure IX -K of AIS -038 
are not stipulate d by the relevant UNECE regulations. Moreover, the "no evidence of fire and 
explosion" requirement in the modified Clause 6.11.4.1 of AIS -156 is also more stringent than the 
relevant requirement in Clause 23A.2.(b) of UN GTR 20. Korea would like to request  India to consider 
revising these overly burdensome requirements in line with the current relevant international 
standards.  
2.86.   Second, Clause 2 of the aforementioned Annexures stipulates certification requirements per 
Indian Standard (IS) 16893 -Part 2 and Par t 3 for cells used to make REESS. However, because most 
of the tests in Part 2 are also covered in Part 3, the requirement places the unnecessary burden of 
duplicative tests on manufacturers. Since IS 16893 -Part 3 stipulates clear safety criteria, Korea 
would like to request that India modify Clause 2 so that the cells can be certified in accordance with 
IS 16893 Part 3 only. Third, it is not appropriate to limit the charge -discharge testing conditions for 
the battery cell formation to the C/3 current rate conditions. Charging and discharging conditions 
may vary depending on the cells' chemical properties and the design. Moreover, if the charge -
discharge operation is performed at a constant speed, it will be difficult to carry out performance 
tests under par ticular conditions, such as fast charging. Therefore, Korea would like to request that 
India consider revising the Automotive Standards to allow charge -discharge tests to be carried out 
under the conditions declared by the manufacturers as suitable for eac h cell product. In addition, as 
the technical contents of the mandatory Automotive Standards deviate considerably from relevant 
international standards, Korea would like to request that India notify other Committee Members, 
receive comments from them, take  their comments into consideration and improve the Standards 
in accordance with the WTO TBT Agreement.  
2.87.   The representative of the European Union  provided the following statement. The EU welcomes 
India's efforts on improving safety of its electric vehicles' fleet. In this regard, India's increasingly 
proactive involvement in the work of the UN's informal working group on safety of electric vehicles, 
in the recent years, is particularly lauded. The EU was pleased to learn that India was preparing 
revision 2 to  the AIS 038 standard, which was largely based on the requirements of UN GTR 20. The 
latter have been judiciously developed to support continuous technological development of different 
battery architectures and solutions, while ensuring the highest levels of vehicle and battery safety; 
and EU manufacturers were working to meet these implementation deadlines. However, the EU 
would like to remind India about the obligation to notify to the WTO any amendments to the AIS 
038 standard, to ensure that all concern ed stakeholders get the opportunity to send comments. The 
EU understands that during 2022 a series of incidences of battery related fires primarily in the two - 
wheelers vehicles have been reported. This unfortunate development has led India to introduce 
amendments of the proposed revision 2 of the AIS 038 standard that will significantly deviate from 
the internationally agreed rules, i.e. UN GTR 20.  
2.88.   India failed to notify to the TBT Committee the amendments 2 and 3 to the revision 2 of the 
AIS 038 standard,  thus going against Article 2.9.2 of the TBT Agreement that requires Members to 
 
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  notify at an early appropriate stage, when amendments can still be introduced and comments taken 
into account. Given that the amendments in question will have a significant eff ect on trade, the EU 
calls on India to suspend the planned entry into force of amendment 3 currently planned for 
1 December 2022 for Phase 1 requirements, and 31 March 2023 for Phase 2 requirements, and to 
notify to the WTO allowing Members customary 60 da ys to present their comments in writing and 
take these written comments into account. The EU finds amendments 2 and 3 to the revision 2 of 
the AIS 038 standard highly problematic, since they are design restrictive and require drastic 
changes to the design of battery systems over an impossibly short period of time, which will lead to 
additional development efforts/cost for vehicle manufacturers without adding safety benefits. 
Moreover, the logic of applying specific safety performance requirements that are m eant to address 
the difficulties encountered on the market of two -wheelers to a category of motor vehicles (four - 
wheelers), at the least as far the EU production is concerned, seems highly inappropriate. The EU 
kindly requests India to fully align the rev ision 2 of the AIS 038 to UN GTR 20, to reconsider the 
lead times imposed on the industry, and to consider accepting type approvals and test reports that 
are based on the provisions of UN GTR 20 (e.g. UNR 100.03).  
2.89.   In response, the representative of India provided the following statement. India has taken 
note of the concerns raised by Korea and the EU today on the Indian automotive industry standards. 
These concerns are currently being examined in the capital. India will be reverting on the issues 
raised in due course.  
2.1.3.14   United States - Energy Conservation Program: Test Procedure for Television 
Sets, G/TBT/N/USA/677/Rev.1  (ID 77518) 
2.90.   The representative of China  provided the following statement. According to the draft 
regulation, the stability criteria of the standby mode measurement is 240 minutes, i.e. six hours. 
However, when the calculation of AEC is performed, hours per day spent in on mode is prescribed 
as five hours, which seems unreasonable. We recommend to modify Table III.2 via adjusting hours 
per day spent in on mode to six hours to be consistent with the requirements for stability. According 
to 5.2.4 of the draft regulation, the calculation of On Mode Power Consumption has been modified 
to use the average of the power consumption in the default SDR, brightest SDR, and default HDR10 
preset picture setting. We propose to retain the provision of the current standard with only the 
default SDR preset picture  setting power as the on mode power consumption since most users are 
used to choosing the default SDR preset picture setting as the daily watch mode. In addition, even 
if the power of SDR brightest and default HDR10 preset picture setting need to be includ ed in the 
power calculation of on mode power consumption calculation, they cannot have the same weighting 
factor as the default SDR preset picture setting power, as the brightest SDR and default HDR10 
preset picture setting are relatively not frequently us ed. For example, the power weighting factor of 
the brightest SDR and default HDR10 preset picture settings should be defined as 0.2, the power 
weighting factor of the default SDR preset picture setting be defined as 0.6, and the calculation 
equation of On Mode Power Consumption should be modified accordingly. Finally, there are three 
power values respectively listed in sections 5.2.1.2, 5.2.2.2, and 5.2.3.2 of the draft regulation, 
which are required to be tested respectively but not referenced in Appendix H, which will increase 
unnecessary test burdens to enterprises. We suggest the US cancel the three power values 
mentioned above.  
2.91.   In response, the representative of the United States  provided the following statement. United 
States thanks China for bringing to the United States attention your concerns about this draft 
regulation. The United States has not received any written comments from China through the US 
Technical Barriers to Trade Enquiry Point. nor has the United States received any comments from 
China in the US Federal Register Docket or Regulations.gov. If China replies to the notification with 
comments by the deadline, the United States responds to all comments publicly when issuing the 
final regulation. In addition, having written comments in advan ce of the WTO TBT Committee aids 
other Members' understanding of what the trade concerns or questions might be. China repeatedly 
raised US Department of Energy rules on the TBT Committee agenda, and has seldom provided a 
comment for us to address in the ru lemaking process. This seems like a false opportunity to raise 
an issue against the United States in this forum.  
 
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  2.1.3.15   Angola - Decreto Executivo n°186/22 by the Ministerio das Finanças (ID 77619) 
2.92.   The representative of the European Union  provided the following s tatement. On 10 March 
2022, Angola published the Executive Decree n°149/22 introducing the obligation to affix High 
Security Tax Stamps on certain products including beverages (beer, wine, spirits, soft drinks) and 
tobacco in order to fight smuggling. This  decree was supposed to enter into force on 10 April 2022. 
On 8 April 2022, the Angolan authorities published the Executive Decree n°186/22, which suspended 
the mandatory affixing of high -security tax stamps on all alcoholic beverages. There is so far no 
revised decree, but the entry into force seems to be currently around April 2023. Angola has not yet 
notified this draft measure to the TBT Committee and we request Angola to notify as soon as 
possible, so that all members can provide their comments on the draft measure well ahead of the 
adoption and entry into force. The EU was having different concerns with the draft measure: Lack 
of consultation and early information of economic operators. Many elements were unclear, both in 
terms of requirements for econ omic operators (certification, registration on the economic platform) 
and in terms of preparatory work by the Angolan authorities (creation of electronic platform, of the 
digital forms etc.). For example, economic operators would have had to order and buy tax stamps 
on the economic platform provided by Prosefa, for which prior registration would be required, but 
the platform itself was not ready. Also experience so far is that this registration/certification 
processes in Angola are very slow.  
2.93.   There was no f lexibility foreseen on where to affix the stamp (i.e., either at production site or 
bonded warehouses) for imported beverages, which represented a significant source of 
administrative burden for imported beverages. Each retail package must have this tax st amp. 
International products cannot be re -packed in Angola, so they must have the stamp from the origin 
country. Absence of a proper transition period following publication of the decree. Such a transition 
period should last at least one year, and a stock e xhaustion clause should be foreseen. However, in 
the previous text, products produced or imported before entry into force of the regulation were only 
going to be authorized on the market for a maximum period of 6 (six) months and no stock 
exhaustion clause  was foreseen. Very high cost of tax stamps compared with other countries in the 
region. The measure did not seem justified for low value drinks such as soft drinks or beer as they 
are not very likely counterfeited and the relative cost of marking is very high. We ask Angola to 
inform us what their plans are for next steps. It is very important to notify a new draft decree to the 
WTO TBT committee well in advance and to consult with all relevant stakeholders and take their 
comments into account. In any case  a transition period of at least one year as well as a stock 
exhausting clause should be foreseen. We would be grateful if Angola could take these concerns into 
account. We are ready to engage in bilateral discussions in order to clarify the issue further.  
2.94.   In response, the representative of Angola  provided the following statement. The Executive 
Decree no. 149/22 of the Ministry of Finance, which establishes the procedures applicable to the use 
of High Security Tax Stamps, suspended by Executive Decree no. 1 86/22, derives from the approval 
and publication of Presidential Decree no. 216/19 of 15 July which creates the National Programme 
for High Security Tax Stamps (PROSEFA) and establishes the mandatory affixing of High Security 
Tax Stamps on liquids and alco holic beverages, tobacco and its manufactured substances, as well 
as Law n. 16/21 of 19 July, the Excise Tax Law, which in turn extends the affixing of Tax Stamps to 
sweetened and carbonated beverages. It should be noted that the High Security Tax Stamps, under 
the terms of the aforementioned Presidential Decree, are intended to combat smuggling and 
counterfeiting of covered products, protect revenue due to the State, and ensure the reliability of 
products introduced into Angolan territory.  
2.95.   In this context,  following the referred suspension, which resulted from a consultation with the 
economic operators on February 2022, who claimed to need a period of one year to adjust their 
factory structures to the requirements of the obligation in question, the Angolan government 
continued the Accompanied Implementation Programme with the economic operators who 
voluntarily expressed an interest, visited manufacturing units at national and international levels, 
especially in the Portuguese, Brazilian and South African mar kets, taking into account the volume of 
products imported from those countries, to assess the respective conditions for compliance with this 
requirement. However, we remain available to provide the necessary assistance to other importing 
companies and mark ets within the scope of this process. As a result, and with a view to improving 
the functionality of the programme under analysis, following the suspension of Decree 149/22, the 
Angolan government has realized the need to introduce relevant content to the new proposed 
 
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  Regulation, namely the provisions on the registration of economic operators on the PROSEFA 
platform and the process of requisition, a strong reduction on the price of tax stamps, the possibility 
of local producers and importers to choose the t ype of tax stamps to acquire, an increase from 1 to 
3% in the quantity of unused stamps that can be justified under the Simplified Procedure, the 
exceptionality of imported products being able to be stamped in national territory, transitional 
provisions, t he supply, return and destruction of tax stamps, among others, having even shared the 
respective proposal with interested parties, mainly the economic operators registered in our tax data 
base, for their respective contributions, a process that is currentl y being concluded for subsequent 
submission for approval purposes.  
2.96.   Regarding the transitional period of six months after publication and entry into force of the 
Regulation on Compulsory Sealing, we consider this period to be more than sufficient, as the av erage 
transitional period for similar programmes implemented in other countries is three months. 
Additionally, we inform that the aforementioned provision has been improved, and the issue of 
products in stock produced before the entry into force of the obl igation has been taken into account. 
Thus, we propose that the products in stock which are not sold after the transitional period should 
have the tax stamps affixed, in order to boost the achievement of the objectives proposed by 
PROSEFA. With regard to th e price of tax stamps, considered by the EU to be high compared to other 
countries in the region, we inform that following the consultation process with economic operators, 
combined with benchmarking on the prices applied in other countries around the regi on and the 
respective tax obligations, the revised Proposed Regulation includes an updated price of tax stamps, 
which reflects a 54% reduction compared to the amount initially provided, positioning Angola as the 
country with the lowest tax burden on the pr oducts covered. It should be noted that the smuggling 
and counterfeiting of alcoholic beverages, as a whole, has become a problem on a global scale, also 
affecting Angola, where this phenomenon is extensive to beers and ciders, according to evidence 
obtain ed in the national informal market. Nevertheless, assuming that beers and ciders are 
considered to be low risk for smuggling and counterfeiting, this measure will necessarily help to 
reduce these levels, discouraging their increase and providing a fair com mercial environment 
between the national and imported products involved, thereby safeguarding the public interest in 
terms of unfair competition and protecting the revenue owed to the State, among other benefits.  
2.1.3.16   European Union - Proposed reduction of Chro mium VI concentration from 
3mg/kg to 1mg/kg in leather and textile items (ID 77720) 
2.97.   The representative of India provided the following statement. India expresses serious concern 
over the EU's proposed reduction of Chromium VI in leather and textiles items from the present limit 
of 3 mg/kg to 1 mg/kg. In general parlance, it is known that some 85% of global leather manufacture 
is carried out using Chromium III salts. Chromium tanning is preferred for cost, speed of production 
and the properties of leather pr oduced. Other tanning chemistries are available, including synthetic 
tannages (syntans) and tanning with vegetable extracts (vegtan). However, these chemistries 
produce leathers with different properties and cannot necessarily be used as a substitute for 
chromium tanning. Moreover, testing methods are not available to accurately measure Chromium 
VI below 3mg/kg. The current ion -chromatography method (which could be more accurate) requires 
expensive analytical equipment and appropriately trained operators. A s such, the manufacturers are 
either unable to test chrome -tanned leathers or almost certainly increased testing costs.  
2.98.   In this regard, the Committee for Socio -Economic Analysis (SEAC), European Chemicals 
Agency also considers that a 1 mg/kg limit may not  be technically feasible as the currently applied 
standard for sampling and analyses EN ISO 17075 does not support reliable quantification lower 
than 3 mg/kg'. With this understanding, the proposed regulation on reducing Chromium VI 
concentration in leathe r and textile items seems technically infeasible and scientifically baseless. 
India reminds the EU that any regulation must be based on sound scientific evidence and should be 
practicable in terms of commercial viability. In light of this common understand ing shared across 
the globe, India requests the EU to withdraw the proposed reduction of Chromium VI concentration 
in leather and textile items from 3 mg/kg to 1 mg/kg as the same stands without sufficient scientific 
evidence; and to consequentially avoid causing unnecessary disruption to safe trade.  
2.99.   In response, the representative of the European Union  provided the following statement. 
Thank you chair and thank you to India for pro -actively raising their concerns. At this moment in 
time, the EU is still ex ploring the appropriateness of such a measure at technical level. This is why 
 
20 For previous statements follow the thread under ID 777 . G/TBT/M/88  
 
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  the measure has not yet been notified to the WTO. If, and when, such a measure is proposed, the 
European Commission will consult the WTO Members, in accordance to its obligations  under the TBT 
agreement. The European Commission takes note of India's concerns, and invites India to submit 
their concerns in writing if and when such a measure is notified. As is usual, the EU will duly take 
India's concerns into account and it can expe ct a response in writing on any written concerns raised 
in the context of the TBT consultation.  
2.1.3.17   Indonesia - Draft decree regarding Minimum Energy Performance (SKEM) and 
Energy Saving Label for various products, G/TBT/N/IDN/141 ; G/TBT/N/IDN/142 ; 
G/TBT/N/IDN/143 ; G/TBT/N/IDN/144 ; G/TBT/N/IDN/145 ; G/TBT/N/IDN/146 ; 
G/TBT/N/IDN/147 ; G/TBT/N/IDN/148 ; G/TBT/N/IDN/149  (ID 77821) 
2.100.   The repres entative of India provided the following statement. India would like to thank 
Indonesia for notifying Members via G/TBT/N/IDN/141  to G/TBT/N/IDN/149  regarding the Minimum 
Energy Performance (SKEM) and Energy Saving Label of various products. As the technical 
documents are in Indonesian, India requests Indon esia to share the officially translated versions in 
English at the earliest. India understands that the draft decree requires domestic manufacturers and 
importers to submit a report regarding the application of Minimum Energy Performance Standards 
to the D irector General of New, Renewable Energy and Energy Conservation periodically every three 
months, which includes brand, type, variant, or model, capacity, power and amount. India is 
concerned that this frequent reporting not only imposes a significant burd en on the manufacturers 
and importers but also has cost implications with limited added value. India, therefore, requests 
Indonesia to review this frequent reporting requirement and ensure smooth trade in compliant 
goods.  
2.101.   In response, the representative of  Indonesia  provided the following statement. Indonesia 
would like to thank India for raising this issue although we have not yet received any questions or 
enquiries from India WTO TBT Enquiry Point regarding any substantive or technical issues of this 
notification. Nevertheless, we will try to explain about Minimum Energy Performance Standards 
(SKEM) and energy saving labels on products. The Indonesian Energy Conservation Program aims 
to provide users with information on the selection of energy -efficient eq uipment for specific energy 
uses. This policy regulates the obligation to include Minimum Energy Performance Standards (SKEM) 
and energy saving labels on products. Minimum Energy Performance Standard (SKEM) is a 
specification that contains a number of mini mum energy performance requirements under certain 
conditions to limit the maximum permissible amount of energy consumption of a product. Energy 
Saving Label is a label that certifies that the product of energy use equipment has met certain energy 
saving re quirements. The standards and conformity assessment procedures used in the 
implementation of this programme have referred to the relevant international provisions. Indonesia 
will take into consideration all comments received during the open comment period of the notification 
(until 2  December 2022) and respond the comments respectively.  
2.1.3.18   Morocco - Conformity assessment, G/TBT/N/MAR/28  (ID 77922) 
2.102.   The representative of the European Union  provided the following statement. On 18 
December 2019 Morocco notified to the WTO TBT Committee the v erification of conformity of certain 
imported industrial goods under reference G/TBT/N/MAR/28 . The EU sent comments in January 2020 
and also followed up with a bilateral discussion and two letters. Despite these discussions concerns 
remain on the EU side. As regards the conformity co ntrol system for industrial products, Morocco 
informed us that the legislative framework does not make a distinction on the basis of the typology 
of economic operators (importers or local manufacturers) or the origin of the products. However, in 
the light of the information available to the EU and based on feedback from our industry, it appears 
that the arrangements for checking compliance vary depending on whether imported or local 
products are concerned. Since the introduction of the new system in Februar y 2020, checks on 
imported industrial products have been outsourced and appear to require the systematic obtaining 
of a certificate of conformity issued by one of the approved bodies, which is very burdensome and 
costly. On the other hand, checks on local products are carried out on the basis of a national market 
surveillance plan, and risk -based according to the products in question, so not on a systematic basis. 
This difference in treatment seems problematic to us.  
 
21 For previous statements follow the thread under ID 778 . 
22 For previous statements follow the thread under ID 779 . G/TBT/M/88  
 
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  2.103.   The TBT Agreement (Article 5.1) provides  that conformity assessment procedures should be 
prepared, adopted and applied so as to grant access to suppliers of like products originating in other 
Members under conditions no less favourable than those accorded to suppliers of like products of 
nationa l origin, in a comparable situation. The Moroccan conformity assessment procedure for the 
respective products creates an unnecessary obstacle to international trade as the procedures seems 
more strict than necessary to give Morocco adequate confidence that  products conform with the 
requirements set out in technical regulations. In this respect some aspects of the procedures need 
to be clarified, like whether there is any possibility for importers to avoid repeating the conformity 
assessment procedure for an y shipment to Morocco, which seems to be unnecessarily burdensome 
in particular for less risky products. Moreover, for Morocco's technical regulations that impose the 
use of Moroccan standards corresponding to international and EU standards, Morocco should  accept 
EU certificates that are based on the same international and EU standards and done by ILAC 
laboratories like a lot of countries are doing world -wide. Another important problem that we face is 
that some Moroccan regulations depart from international  standards without providing an adequate 
justification for it. The standardization process and the subsequent transformation of the national 
standards into compulsory technical regulations also raises questions of transparency. We would be 
grateful if Moro cco could take these concerns into account and work on the review of their conformity 
assessment system. We are ready to engage in bilateral discussions in order to clarify the issue 
further.  
2.104.   The representative of Morocco  did not provide a response to the concerns raised.  
2.1.3.19   India - Order related to requirement of Health certificate accompanied with 
imported food consignment of Milk and Milk Products, Pork and Pork Products & Fish and 
Fish Products, G/TBT/N/IND/233  (ID 78023) 
2.105.   The representative of the European Union  provided the follo wing statement. In relation to 
the Order that introduces three new health certificates to accompany the imported food 
consignments of milk and milk products, pork and pork products and fish and fishery products, the 
European Union would like to start by we lcoming the notification of India ref. G/TBT/N/IND/233  of 
18 August 2022, while asking India to please reply in written to the EU comments, given the 
importance of providing exporting countries with clarity and certainty about India's import 
requirements; and the two months postpon ement, pursuant to the FSSAI Order of 27 October 2022, 
of the entering into force of the new health certificates − from 1 November 2022 to 1 January 2023. 
However, given the: (i)  disruption to trade associated to the new certificates, even if they are not 
associated to new sanitary measures; (ii) number of unanswered questions by India; (iii) duplication 
of certificates requested by different authorities in India; (iv) different products/food categories 
associated to the three certificates and to the regist ration of foreign food manufacturing facilities; 
and (v) importance of the competent authorities and companies in the exporting countries to have 
sufficient time to adapt, the EU would like to ask India to: Further postpone the date of entering into 
force for, at least, 12 months; Clarify the meaning of "entering into force ", i.e. whether it 
corresponds to the "date of arrival of the consignments to India" or the "date of departure of the 
consignments from the exporting countries"; Provide a list of HS prod uct codes with, at least, 4 
digits, and the risks associated to each of the products/food categories; Make easily accessible, at 
all times, the import sanitary measures of India (Regulations), which are applicable to each of the 
types of products associate d to the three health certificates; Clarify the modalities related to "regular 
inspections/monitoring of checks in accordance with the FSS Act, 2006 ", as mentioned in the three 
certificates; Consider avoiding the duplication of sanitary measures in differe nt certificates for the 
import of the same products, which are required by different competent authorities of India; 
Consider negotiating with the EU "harmonized model certificates " that would be applicable for 
exports from the entire EU, i.e. that would b e signed by the competent authorities of all EU member 
States; Notify, well in advance, its measures related to the new health certificates also to the WTO 
SPS Committee. Finally the EU would like to thank India for its willingness to meet to discuss all 
these matters.  
2.106.   The representative of New Zealand  provided the following statement. New Zealand would 
like to thank the Food Safety and Standards Authority of India (FSSAI) for the discussions to date 
on this new requirement and extending the implementation date. We seek confirmation that a single 
health certificate will be accepted for affected commodities by FSSAI, the Department of Animal 
Husbandry and Dairying, and the Department of Fisheries. New Zealand is concerned with the 
 
23 For previous statements follow the thread under ID 780 . G/TBT/M/88  
 
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  requirement to provide assur ances that operators comply with Indian domestic regulations and 
standards, as outlined in the new requirements. We note that the WTO SPS Agreement provides for 
the recognition of the regulatory system and controls of the exporting country as achieving the  
sanitary criteria and objectives required by the importing country. New Zealand encourages India to 
recognize that the food safety regulatory system of an exporting country can achieve the food safety 
outcomes of India's regulations and standards. We are also concerned that there is limited time to 
agree and implement revised certification which meets the needs of FSSAI, the Department of 
Animal Husbandry and Dairying, and the Department of Fisheries by the 1 January 2023 deadline. 
We request that existing  certification continue to be accepted while India negotiates revised 
certification requirements with its trading partners and that a transition period be provided to enable 
implementation of any revised certification.  
2.107.   The representative of Canada  provided the following statement. Canada is concerned that 
India's measure will result in the duplication of health certificate requirements and create 
unnecessary regulatory and administrative cost for these commodities. Canad a strongly encourages 
India to streamline certification requirements, and have a single integrated certificate incorporating 
food safety related requirements and attestations accepted by FSSAI. Therefore, Canada welcomes 
India's recent decision to allow FS SAI's new requirements to be integrated into existing certificates 
so that a single certificate can be issued, as indicated on the 26 September 2022, clarification notice. 
However, Canada remains concerns on the implementation of a proposed single certific ate. Canada 
looks forward to India's response to our comment letter submitted on 17 October 2022, including 
on the timeline for India providing the requested details. For example, Canada would appreciate 
clarification from India regarding the impact of thi s measure with certificates that are currently under 
negotiation with India's Department of Animal Husbandry and Dairying. Canada will avail itself of 
the opportunity to negotiate with India on revised certificates incorporating food safety related 
require ments and attestations according to international standards. However, Canada notes that 
this will take time. While Canada appreciates that FSSAI has delayed the implementation date of 
this order to 1 January 2023, Canada urges FSSAI to further delay implem entation until the revised 
single certificates are finalized. In closing, Canada requests India to notify these new requirements 
to the SPS Committee given that India's proposed regulation covers food safety measures aimed at 
protecting human health and sa fety. 
2.108.   The representative of the United States  provided the following statement. The United States 
supports the concerns raised by the European Union regarding India's new health certificate for milk, 
pork, and fisheries products to this meeting's agenda. We look forward to receiving a response from 
India to the comments we submitted on 18 October 2022.  
2.109.   The representative of Japan  provided the following statement. Japan shares the concerns 
expressed by EU regarding India's Order related to requirement of health certificate accompanied 
with imported foo d consignment of milk, pork, fish and related products. According to the India's 
TBT notification, the final date for comments was set as the middle of October 2022, and proposed 
date of adoption and entry into force of the Order was advised as 1 November 2022, which was just 
two weeks after the closing date for comments. Our concern is that the Indian authority would not 
have sufficient time to consider any comments put forward before the implementation. In addition, 
as late as 27 October, only five days b efore the scheduled date of entry into force of the new rules, 
India announced that it would be extended by two months (i.e., 1 January 2023). Although Japan 
appreciates India's decision on the extension, it should have been announced well in advance to 
avoid any unnecessary confusion and a negative impact on trade. Moreover, in order to allow time 
for exporting Members to adapt to the new health certificate forms, Japan requests India to allow a 
reasonable interval between their publication and entry into force. Japan would like to thank India 
for its willingness to discuss this issue bilaterally. Last but not least, Japan notes that one of the 
objectives of India's Order is to ensure the safety of imported food products into India. If that is the 
case, Jap an considers that India should notify the Order under the SPS Agreement as well.  
2.110.   The representative of Australia  provided the following statement. Australia shares the 
concerns raised by the European Union and supported by New Zealand, Canada, United State s and 
Japan on this issue. We would like to refer India to the comments Australia submitted on notification 
G/TBT/N/IND/233  on 17 October 2022. We welcome India's response to our concerns.   
2.111.   In response, the representative of India provided the following statement. The requirement 
of export certificate for categories of food products as specified by the Food Authority is one of the 
mandatory requirement as per the regulatory provision prescribed in Chapter "Risk based framework G/TBT/M/88  
 
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  for import clearance " under Clause 11.2(b) of Food Safe ty and Standards (Import) Regulations 2017. 
In view of the above, to envisage robust food safety and monitoring system, FSSAI has notified the 
requirement of Health Certificate to be accompanied with all imported consignments of Milk and Milk 
products, Por k and Pork products, and Fish and Fish products which was to be enforced from 
1 November 2022. Further, the major purpose of providing this requirement is to ensure that the 
product is manufactured in accordance with the requirements/provisions of the Food  Safety and 
Standards Regulations. The requirement was notified in WTO -TBT for comments/inputs from the 
Members. Various concerns regarding the number of certificates and extension for implementation 
of the same was received from Member countries. To addre ss the concerns raised by Member 
countries, the enforcement of requirement for Health certificate was extended till 1 January 2023 
vide FSSAI order dated 27 October 2022. Further, FSSAI vide order dated 26 September 2022 issued 
a clarification stating that  an integrated/single certificate incorporating all food safety related 
requirements/attestations as specified in the format notified on 3 August 2022, would also be 
accepted by FSSAI at the time of import clearance. The requirement of Health certificate i s a pre -
import requirement, which is only an assurance provided by the Competent Authorities of exporting 
countries that the food products (as notified) are in compliance with safety requirements as specified 
by FSSAI.  
2.1.3.20   Brazil - 67 notifications issued over  the last six months covering chemical and 
pharma products without adequate timeframe to respond (ID 78124) 
2.112.   The representative of India provided the following statement. India would like to thank Brazil 
for its continued transparency in notifying TBT Commi ttee about various Technical Regulations and 
Conformity Assessment Procedures. However, India is concerned that Brazil has adopted technical 
regulations without sufficient time for its trading partners to review, offer comments, or adapt to 
Brazil's requir ements. Brazil issued 82 TBT notifications during the first six months of financial year 
2021-22. Of the 82 notifications, in 67 notifications, Brazil needed to provide adequate time for the 
other Members to offer their comments. It has also been noted tha t many of the measures adopted 
by Brazil between May 2022 -October 2022 have an average time gap of only one month between 
their publication date and adoption. Further, the technical documents are available in Portuguese 
and not English. Limited English ref erence documents are available for further analysis of the said 
notifications. Such non -availability of official English -translated versions is causing considerable 
difficulty in examining the exact contents and requirements of the regulations. Consequentl y, it is 
difficult to understand the requirements to be followed by Indian exporters precisely. In accordance 
with Article 2.12 of the TBT Agreement, Brazil is required to allow a reasonable interval of no less 
than six months between the publication of th e measure and its entry into force. India kindly invites 
Brazil to ensure compliance with this obligation to ensure that the relevant stakeholders in exporting 
countries have sufficient time to adapt to the evolving regulatory regime. We also thank the 
delegation of Brazil for their very constructive engagement this week. We had sought some 
additional information on this STC and will provide that in the coming days.  
2.113.   In response, the representative of Brazil  provided the following statement. Brazil thanks 
India for its statement and is keen to open a dialogue on the timeframes of our notifications. We are 
already discussing this matter bilaterally in order to clarify the reasons for this STC. We would just 
like to note, however, that we can only convey a prel iminary reaction at this point, as we do not 
have a specific list of the 67 notifications about which India raised this issue. As the top 3 Member 
in terms of number of TBT notifications, Brazil would like to reaffirm its commitment to transparency 
and ass ure that we follow the good regulatory practices recommended by the WTO. As a general 
rule, we open and notify public consultations about proposed technical regulations with reasonable 
time for other Members to make comments, as prescribed in Article 2.9 o f the TBT Agreement. 
Considering these general and preliminary comments, Brazil would like to invite India to provide 
more information about its STC, including specific notifications or regulations which need to be 
clarified.  
 
24 For previous statements follow the thread under ID 781 . G/TBT/M/88  
 
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  2.1.4   Previously raised concerns  
2.1.4.1   China - Requirements for information security products, including, inter alia, the 
Office of State Commercial Cryptography Administration (OSCCA) 1999 Regulation on 
commercial encryption products and its on -going revision and the Multi -Level Protection 
Scheme  (MLPS) (ID 29425) 
2.114.   The representative of Japan  provided the following statement. Japan continues to have 
concerns regarding China's Regulation on Commercial Encryption Products and Cybersecurity Multi -
Level Protection Scheme. Japan would like to refer to t he previous statement we made at the last 
TBT Committee in July 2022. Japan would like to continue to request that China provide relevant 
information regarding the current revision process of the Regulation on Commercial Encryption 
Products that was subjec t to public consultation up to 19 September 2020, and the current drafting 
process of the Cybersecurity Multi -Level Protection Scheme that China described at the last TBT 
Committee, and that those regulations are to be implemented transparently.  
2.115.   The repres entative of the European Union  provided the following statement. Regarding the 
Multi-Level Protection Scheme (MLPS), the EU would like to refer to its comments raised at previous 
TBT Committee meetings, specifically concerns around the unwarranted and sign ificant market entry 
restrictions, including by demanding that all networks above Level 3 be subject to certain legal 
obligations that were originally destined for Critical Information Infrastructure (CII). The EU calls for 
enhanced proportionality and tra nsparency in the implementation of the Cyber -MLPS.  
2.116.   In response, the representative of China  provided the following statement. With regard to 
the management of commercial encryption products, China has cancelled the approval of varieties 
and models of comme rcial encryption products from 1 January 2020, and established a unified 
certification scheme for commercial cryptography. The management of commercial encryption 
products fully reflects the principles of non -discrimination and fair competition. It treats domestic 
and foreign products and companies equally. China implements mandatory testing and certification 
on commercial encryption products that involve national security, national economy, people's 
livelihood, and public interest, and implements voluntary  testing and certification on other 
commercial encryption products. To protect China's network and data security, in 2007, China 
enacted Measures for the Administration of Classified Protection of Information Security and began 
to implement the Classified Protection of Information Security (now called Classified Protection of 
Cybersecurity) system. In 2016, the Cybersecurity Law of China stipulates that the state shall 
implement the system for classified protection of cybersecurity, thus establishing the le gal status of 
the system. The system for classified protection of cybersecurity has become a basic national policy 
and system in the field of cybersecurity in China and has played an essential role in the maintenance 
and protection of cybersecurity.  
2.117.   As req uired by the system, the protected objects, such as information systems, are divided 
into five levels based on respective importance and the harm when damaged. Operators for level II 
and above shall file records to the public security authority. Operators shall determine the level 
based on relevant national normative documents, technical standards, and objects' own actual 
situation, and implement different protection strategies respectively, to effectively strengthen 
protection for the network and data. Thi s is consistent with common international practices.  
2.1.4.2   China - Cyberspace Administration of China – Draft implementing measures for 
the Cybersecurity Review of Network Products and Services (ID 53326) 
2.118.   The representative of Japan  provided the following statem ent. Japan continues to have 
interest in and concerns regarding the Cybersecurity Review and would like to refer to the previous 
statement we made at the last TBT Committee in July 2022. China enforced the amendment of the 
Measures for Cybersecurity Review  in February 2022. It is unclear whether the definition and scope 
of "Critical Information Infrastructure Operator " refers to the definition of "Critical Information 
Infrastructure" provided under the Regulations on the Security Protection of Critical Info rmation 
Infrastructure, and there is no definition for "Network Platform Operator. " Therefore, it is uncertain 
what kind of businesses could be subject to the Measures for Cybersecurity Review. Japan would 
 
25 For previous statements follow the thread under ID 294 . 
26 For previous statements follow the thread under ID 533 . G/TBT/M/88  
 
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  like to request that China operate the regulations  transparently for predictability without hindering 
business.  
2.119.   The representative of the European Union  provided the following statement. The EU has 
raised the Security Review of Network Products and Services, among many aspects of the 
Cybersecurity Review Measures, in this Committee on several occasions, stressing our concerns 
related to these measures, which entered into force on 1 June 2020, were subsequently amended 
in January 2022, and entered into force on 15 February 2022. We remain concerned that the  
measures are quite general and very broad discretionary powers are left to the authorities in charge 
of the security review, raising concerns for foreign ICT operators. The Amended Measures contain 
few explanations of the issues we raised before and new i ssues have arisen since then. The EU 
regrets that the Measures were adopted without a longer grace period, of at least 12 months, so 
that companies would have sufficient time to prepare for compliance with the Amended Measures. 
The Amended Measures have al so significantly increased the scope of application and many 
operators need time to understand their compliance obligations and the related business impact.  
2.120.   The Measures expand the scope of the application from Critical Information Infrastructure 
Operator' s (CIIO) purchase of network products and services, to online platform operators carrying 
out data processing activities. A newly imposed requirement is that online platform operators holding 
personal information of more than one million users, and that ar e newly listed on foreign markets, 
must report for review. The Measures include very broadly defined triggers, such as security, 
openness, transparency and diversity of supply sources, as well as "political, diplomatic and trade 
factors ". The review is per ceived as being lengthy and untransparent, and may subject suppliers to 
exposure of trade secrets. The EU considers that, in this environment, domestic companies may be 
favoured over international ones. It remains unclear who would be a "data processor " or when they 
would be engaged in "data processing activities ". Article 3 of the Data Security Law has something 
of a definition of "Data processing" but the definition states "data processing includes but is not 
limited to… " so therefore remains unclear. Und erstanding the scope of a data processor engaged in 
data processing activities would be necessary to the extent that it determines if and when an 
application would have to be filed. The EU urges China to clarify if "a data processor carrying out 
data proce ssing activities " applies only to a data processor registered in China and processing data 
in China, and excludes overseas data processors that process data outside of China.  
2.121.   The EU seeks clarification on the following points: 1. Based on the previous draf t, entities 
subject to Cybersecurity Reviews have changed from "data processors " to "online platform 
operators ". The final Measures do not define "online platform operators ", but the Draft Regulations 
define it as "data processors who provide Internet platform services such as information publishing, 
social networking, transaction, payment or audio -visual services ". The EU urges China to clarify if 
the scope of "online platform operators " is narrower than "data processors ", which was used 
previously and excludes self -operated e -commerce services of fast -moving consumer goods 
companies that do not provide online platform services. The vagueness of "online platform 
operators " leaves room for interpretation by regulators. 2. Neither "core data " nor "important data " 
are clearly defined. Both Article 21 of the Data Security Law and Article 19 of the Outbound Data 
Transfer Security Assessment Measures include "etc.", which makes any definition even more vague. 
The Measures include important telecommuni cation products as one kind of "network products and 
services ". However, the Measures still do not provide a specific scope of "network products and 
services ". Article 21 of Cybersecurity Review Measures is still much too vague. This leads to the 
definitio n of "important communication product " being even more unclear. The EU urges China to 
clarify these terms as soon as possible. Overall, the EU urges China to ensure clarity, transparency 
and objectiveness in the security review so that the Measure does not  become a market access 
barrier.  
2.122.   In response, the representative of China  provided the following statement. The Chinese 
government administers the Internet in accordance with its laws and regulations. In April 2020, the 
Cyberspace Administration of China a nd 12 other departments jointly formulated the Cybersecurity 
Review Measures, which took effect on 1 June 2020. The Measures for Cybersecurity Review of 
products and services, which came into force on 1 June 2017, was repealed at the same time. In 
2021, th e Cyberspace Administration of China and 13 other departments jointly revised the 
Cybersecurity Review Measures, which took effect on 15 February 2022. The cyber security review 
of the procurement of network products and services by the operators of critic al information 
infrastructure has been carried out in accordance with the National Security Law and the Cyber 
Security Law. Conducting cybersecurity review is necessary to safeguard cybersecurity and national G/TBT/M/88  
 
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  security. It is also a common practice of all M embers, and many Members have taken legal and 
administrative measures in this regard. Opening up is a basic policy of China. China will, as always, 
welcome foreign products and services to enter the Chinese market in compliance with the 
requirements of Chi nese laws and regulations.  
2.1.4.3   India - Quality Control Orders for Chemical and Petrochemical Substances, 
G/TBT/N/IND/116 , G/TBT/N/IND/121 , G/TBT/N/IND/122 , G/TBT/N/IND/123 , 
G/TBT/N/IND/124 , G/TBT/N/IND/125 , G/TBT/N/IND/126 , G/TBT/N/IND/127 , 
G/TBT/N/IND/128 , G/TBT/N/IND/129 , G/TBT/N/IND/130 , G/TBT/N/IND/132 , 
G/TBT/N/IND/133 , G/TBT/N/IND/134 , G/TBT/N/IND/135 , G/TBT/N/IND/136 , 
G/TBT/N/IND/137 , G/TBT/N/IND/138 , G/TBT/N/IND/139 , G/TBT/N/IND/140 , 
G/TBT/N/IND/141 , G/TBT/N/IND/142 , G/TBT/N/IND/144 , G/TBT/N/IND/150 , 
G/TBT/N/IND/151 , G/TBT/N/IND/152 , G/TBT/N/IND/153 , G/TBT/N/IND/154 , 
G/TBT/N/IND/175 , G/TBT/N/IND/176 , G/TBT/N/IND/177 , G/TBT/N/IND/186 , 
G/TBT/N/IND/187 , G/TBT/N/IND/191 , G/TBT/N/IND/193 , G/TBT/N/IND/199 , 
G/TBT/N/IND/201 , G/TBT/N/IND/202 , G/TBT/N/IND/203 , G/TBT/N/IND/204 , 
G/TBT/N/IND/205 , G/TBT/N/IND/206 , G/TBT/N/IND/208  (ID 63027) 
2.123.   The representative of the United States  provided the following statement. We remain 
concerned by India's Quality Control Orders (QCOs), and as such, have submitted a document 
summarizing most of our concerns. Please refer to the "W" document we issued with Canada and 
Chinese Taipei on India's Quality Control Orders in G/TBT/W/774 , as we will not reiterate all those 
concerns here. India's Ministry of Chemicals and Fertilizers has notified 44 QCOs to the WTO TBT 
Committee, each identifying chemicals and petrochemicals for which India intends to mandate 
compliance to standards set by the Bureau of Indian Standards. We continue to reiterate US 
industry's concerns regarding the Polyethylene Material for Molding and Extrusion QCO 2020, notified 
as G/TBT/N/IND/191 . US industry remains concerned about  the measure's labelling requirement 
which mandates markings that must include "designation codes" identifying an array of technical 
information, including melting point, density, processing method, and application. Can India explain 
the objective and audi ence for these labels? We remain interested in understanding how India has 
considered industry input on alternative, cost -effective, and mutually beneficial ways to fulfill India's 
regulatory objectives. How has India considered these proposed alternative options? We continue to 
report US industry's concern that, as proposed, requiring the labelling and affixation of information 
in print, with alphanumerical code unique to India, will impose administrative burdens leading to 
inefficiencies, delays, and addi tional costs for exporters.  
2.124.   The representative of The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu  
provided the following statement. The Separate Customs Territory of Taiwan, Penghu, Kinmen and 
Matsu would like to reiterate its concerns a bout the Order issued by India's Ministry of Chemicals 
and Fertilizers on phthalic anhydride and n -butyl acrylate, and terephthalic acid, which were notified 
by G/TBT/N/IND/116 , G/TBT/N/IND/123  and G/TBT/N/IND/124 . We would like to first thank India 
for postponing the enforcement date of the products concerned until 22 December 2022 . While there 
were practical difficulties in carrying out the on -site inspections for our businesses that have applied 
for BIS certificates due to our previous quarantine requirements for incoming arrivals. The 
quarantine requirements for all arrivals were  cancelled starting 13 October. Hence, we suggest that 
India's BIS inspectors conduct on -site inspections as early as possible so that our manufacturers can 
complete the mandatory certification requirement before the enforcement date of the order. We 
have been following closely India's quality control orders on various products due to the significant 
impact on our exported products. We urge India to refer to G/TBT/W/774  circulated on 11 November 
2022, and consider implementing these measures in accordance with the WTO obligations.  
2.125.   The representative of the European Union  provided the following statement. The European 
Union would like to support the delegations of the United States and Chinese Taipei. The increasing 
number of Quality Control Orders (QCOs) across sectors is sending wo rrying signals to EU industry, 
EU investors, and EU member States as the majority of QCOs introduced by India appear to have 
protectionist orientation and raise question in relation to their compliance with the WTO's TBT 
Agreement obligations. The EU is de eply concerned by the fact that QCOs usually prescribe Indian 
specific standards where international standards already exist. Furthermore, they make mandatory 
conformity assessment procedures that are more restrictive than necessary to fulfil their legitim ate 
objective. The QCOs, in many cases require on -site audit at manufacturers' premises by an auditor 
 
27 For previous statements follow the thread under ID 630 . G/TBT/M/88  
 
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  of the Bureau of Indian Standards (BIS) for products manufactured in third countries to receive the 
approval/licence for exports to India. In view of the huge backlog of applications following COVID -
19 pandemic, the audit exercise is still slow and often results in delays in issuance of licences, which 
has economic impact on trade, as goods cannot be placed in the Indian market without the ISI mark. 
The EU would therefore like to take this opportunity to request Indian authorities to consider 
preparing rules for international recognition of laboratories by the BIS, as foreseen by legislation in 
place. This would speed up audits, and lower the cost of mandato ry testing for foreign 
manufacturers.  
2.126.   The QCOs cause extra burden and economic cost to the EU industry that has to undergo 
cumbersome procedures, including obligatory testing in Indian laboratories, to obtain necessary 
permissions and/or licences for produ cts already tested and certified under established international 
standards. Furthermore, the foreign manufacturers have to make necessary modifications in their 
tooling systems to incorporate the ISI mark. This causes temporary shutdown of production lines  to 
make necessary changes and results in disruption of plant activities as well as in the financial loss 
for the plants during the period of closure. In this context, the QCOs add little value for Indian 
consumers, making the reason of their introduction not evident. The EU systematically takes note 
of all Indian TBT notifications pertaining to Quality Control Orders (QCOs) for chemical and 
petrochemical substances. As already stated in this Committee, some QCO notifications do not have 
a determined date o f entry into force. The EU reiterates its request to India to provide structured 
information regarding the planned time for the adoption of these measures, as well as to provide an 
updated list of chemicals and petrochemicals, which have already been imple mented and of those 
that are yet to be implemented, together with copies of relevant Quality Control Orders. The 
European Union recalls its request for clarifications explaining the reasons for establishing India -
specific Quality Control Orders when these chemical and petrochemical products already comply with 
internationally recognized standards. In accordance with the TBT Agreement, standards are 
considered as voluntary, whereas mandatory standards are considered as technical regulations. 
Article 2.2 of t he TBT Agreement, states that Members shall ensure that technical regulations are 
not prepared, adopted or applied with a view to, or with the effect of, creating unnecessary barriers 
to international trade. The EU would also like to encourage India to ali gn the BIS standards with 
well-established and recognized international approaches.  
2.127.   The representative of Indonesia  provided the following statement. Indonesia thanks India 
for its notification on the Implementation of (Quality Control) Order for Acid Oil,  Coconut Fatty Acid, 
Lauric Acid, and Palm Fatty Acid to the WTO as G/TBT/N/IND/220 , G/TBT/N/IND/221 , 
G/TBT/N/IND/223  and G/TBT/N/IND/224  in November 2021. The Department of Chemicals and 
Petrochemicals, Ministry of Chemicals and Fertilizers of India has issued standard regulations on four 
export products, namely IS 10931.1984; IS 12029.1986; IS 12067.1987; and IS 12069.1987, 
where the products must be certified according to Indian Standards and the manufacturer is required 
to undergo certification by the Indian Standards Bureau (BIS) under Foreign Manufacturer 
Certification (FCMS), before the product is allo wed to enter the Indian market which is valid 181 
days from the date of its issuance, i.e. 24 October 2022. Indonesia appreciates India for the delaying 
the implementation date of the regulation until 24 April 2023, which was announced on 21 October 
2022 i n the India Gazette.  
2.128.   However, the delay time is still insufficient for producers to be able to meet the requirements 
set out in the QCO. With the large number of regulated products, the need of physical testing, and 
the factory inspection requirements at p roduction sites, we are concerned about possible queues 
and backlogs of product certification applications coming into the BIS, which could slow down the 
certification process and hinder the export process. In this regard, we request India to postpone the 
implementation of this QCO until 23 October 2023. Indonesia suggest India to open the option of 
international recognition for conformity assessment result and/or conformity assessment bodies 
(inspection bodies) from the country of origin to not only speed up the audit and certification process, 
but also reduce the cost of certification. In addition, we hope India can refer to the latest 
international standards regarding the technical requirements as well as the required testing 
methods. The existence of up -to-date technology used in this standardized testing method may 
make a difference to the results performed in the country of origin and India. We hope India will 
consider these comments and postpone the implementation of the QCO.  
2.129.   The representative of Singapore  provided the following statement. Singapore would like to 
echo the concerns raised by other Members, and would like to reiterate our concerns expressed at 
the previous meetings of this Committee. In this regard, we note the document circulated by Can ada, G/TBT/M/88  
 
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  Chinese Taipei and the United States under G/TBT/W/774 , and would like to express our support for 
the concerns that are highlighted within the document, many of which are shared by Singapore. 
Singapore remains concerned that India's Quality Control Orders for chemical and petrochemica l 
substances could affect foreign chemical manufacturers' access to the Indian market, given the 
onerous requirements for industry stakeholders to comply with the new measures, some of which 
are not aligned with international standards. We note that some i ndustry players and other Members 
of this Committee have put forth alternatives that can be adopted to smoothen the operational 
implementation of the Quality Control Orders, and would like to encourage India to positively 
consider these suggestions, to ens ure that the mandatory requirements are not too burdensome for 
the industry to comply with. We also respectfully urge India to consider accepting relevant 
international standards, where possible, to avoid duplicative requirements, reduce the industry's 
compliance costs, and ensure that the measures imposed are not more trade -restrictive than 
necessary to fulfil India's regulatory objectives.  
2.130.   The representative of Canada  provided the following statement. In previous Committee 
meetings, Canada raised concerns  over the approach taken by India to make mandatory the use of 
Indian Standards on the regulation of a series of chemical substances. Canada remains of the view 
that the notification process followed by India to inform interested parties of its "Quality Co ntrol 
Orders" (QCO) is problematic, and that a number of systemic issues persist with respect to the QCO 
framework. In this context, Canada joined the room document G/TBT/W/774  which serves to 
highlight these key concerns. We hope that India will be able to address these concerns and that 
India will ensure that the implementation of these measures is conducted in ways that are consistent 
with India's WTO obligations.  
2.131.   In response, the representative of India provided the following statement. We thank the 
delegations of Chinese Taipei, the US , the European Union, Indonesia, Singapore and Canada for 
their comments. The document on India's QCOs shared by the delegation of the US is currently 
under review by the capital. On this specific issue, we would like to highlight the following: The QCO 
requires the products covered to bear a Standard Mark under a valid licence from BIS as per Scheme -
I of the BIS (Conformity Assessment) Regulations, 2018. Under this Scheme, factory inspection is a 
mandatory requirement for the grant of licence. Licence to u se the Standard Mark on a product is 
granted after assessing the manufacturing and testing capabilities through factory inspection of the 
manufacturing premises. During this visit, conformity of the product to the requirements of the 
relevant Indian Standa rd is also established through in -house factory testing or testing at a third -
party testing laboratory or a combination of both. At present, there is no provision in BIS (Conformity 
Assessment) Regulations, 2018, to undertake virtual inspection for conform ity assessment activities 
as an alternative. As the COVID -19 restrictions have eased out, BIS has started carrying out 
inspection where confirmation for travelling of fully vaccinated BIS officers has been received. As on 
date more than 350 preliminary ins pections have already been carried out. However, if in some 
cases inspection are being delayed, it is due to difficulty in getting the visa. In accordance with the 
Code of Good Practice of WTO -TBT Agreement and as a policy, BIS tries to align Indian Standa rds 
with International Standards of ISO and IEC, where available and to the extent possible, considering 
the specific climatic/environmental conditions and technological development in the country. Around 
94% of Indian standards, for which corresponding IS O or IEC standards are available, are 
harmonized with their ISO or IEC counterparts.  
2.1.4.4   India - Indian standards and import restrictions in the automotive sector (Quality 
Control Orders): wheel rims, safety glass, helmets, G/TBT/N/IND/118 , 
G/TBT/N/IND/147 , G/TBT/N/IND/167  (ID 64928) 
2.132.   The representative of the European Union  provided the following statement. The EU would 
like to make a reference to STC No 27 29which contained our position on Quality Control Orders as 
issued by India. This part of our statement and our position on QCOs is also applicable to this specific 
trade  concern. The EU acknowledges the deferment of implementation on QCOs on safety glass and 
wheel rims. However, the EU would like to recall that safety glass and wheel rims manufacturers in 
the EU are subject to a rigorous certification process, in line wit h established international standards, 
which are not much different from the Indian ones introduced by relevant QCOs. The EU reiterates 
its suggestion to keep the BIS marking as optional for components which are already in compliance 
with the UN marking re quirements. The EU would like to ask India if it would be ready to accept 
 
28 For previous statements follow the thread under ID 649 . 
29 India - Quality Control Orders for Chemical and Petrochemical Substances ( ID 630 ). G/TBT/M/88  
 
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  provisionally UN type approvals and markings. In light of this, the EU would like to request India to 
reconsider the introduction of the QCOs on automotive safety glass and wheel rim s. The EU also 
recalls its earlier suggestion to keep the BIS marking as optional for component that are already in 
compliance with the current marking requirements. The EU deeply regrets that India did not consider 
meaningful alternative options to foreig n audits such as audits contracted by internationally 
recognized third agencies/entities. The EU would therefore like to reiterate its request to Indian 
authorities to consider preparing rules for international recognition of laboratories by the BIS as 
foreseen by legislation in place. This would speed up audits and lower the cost of mandatory testing 
for foreign manufacturers. The EU understands that licence has a validity of not less than one year 
and up to two years. The EU would like to ask India to exp lain the process of licence renewal as it 
remains unclear. The current procedure is already unduly cumbersome  and costly. Requiring a 
renewal every two years adds to the difficulty of doing business. At a time when businesses across 
the world have been hea vily impacted by the SARS COV -2 pandemic, it would be important to 
facilitate trade. The EU would like to know whether India consider ed  the possibility of extending the 
validity of authorization beyond two years  
2.133.   In response, the representative of India provided the following statement. We thank the 
European Union for their statement. We also thank the EU for the acknowledgement that the 
proposed entry into force of the concerned QCOs for wheel rims, safety glass and helmets were 
delayed. The QCOs are being  issued for products under mandatory certification as notified by the 
concerned Line Ministries (Regulator) of the Government of India. As per the provisions of the QCO, 
the products specified therein shall bear a Standard Mark under a valid licence from B IS as per 
Scheme -I of the BIS (Conformity Assessment) Regulations, 2018. Under this Scheme, factory 
inspection is a mandatory requirement for the grant of licence. At present, there is no provision in 
BIS (Conformity Assessment) Regulations, 2018, to under take virtual audits for conformity 
assessment activities as an alternative. More than 350 preliminary inspections have already been 
carried out. However, if in some cases inspection are being delayed, it is due to difficulty in getting 
the visa. Further, t he BIS has already granted 9 (nine) licence for safety glass, and 7 (seven) licences 
for wheel rims after the COVID -19 period. We have conveyed the comments made by the EU to the 
capital.  
2.1.4.5   China - Commercial Cryptography Administrative Regulations (ID 64430) 
2.134.   The representative of the European Union  provided the following statement. The EU remains 
concerned about this implementation measure of the Cryptography Law, and sent comments to the 
State Cryptography Administration (SCA) in September 2020. Specificall y, concerns relate to (i) the 
scope of the law; (ii) the protection of intellectual property; (iii) the imposition of pre -market and 
export controls; (iv) the vague requirements around testing and certification, and the turning of 
voluntary certification r equirements into de facto market access prerequisites; (v) the imposition of 
additional "national security reviews"; and (vi) the use of domestic standards, along with the lack of 
meaningful access to pertinent Chinese standards development organisations. The EU urges the SCA 
to address these concerns in the further development of the draft regulations in order to ensure that 
legal and regulatory requirements are applied in a non -discriminatory manner, do not favour specific 
technologies, do not limit marke t access and do not lead to forced transfers of intellectual property. 
Additionally, the EU encourages the SCA to open up, in practice, the Working Group 3 on 
Cryptographic Technology of the National Information Security Standardisation Technical Committee  
(TC260) and the "Cryptography Industry Standardisation Technical Committee" (CISTC) to foreign -
invested industry based in China. The EU would appreciate its comments being taken into 
consideration and invites China to notify the draft regulations to the W TO. 
2.135.   In response, the representative of China  provided the following statement. China welcomes 
the EU's interests in China's commercial cryptography regulation. The Revised Regulations on the 
Administration of Commercial Cryptography have been included in t he State Council Legislation Plan 
for 2022. The revision of the regulations follows law -based, democratic, and scientific principles. It 
will be open and transparent.  
 
30 For previous statements follow the thread under ID 644 . G/TBT/M/88  
 
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  2.1.4.6   Mexico - Conformity Assessment Procedure under Mexican Official Standard NOM -
223-SCFI/SAG ARPA - 2018, "Cheese Names, Specifications, Commercial Information, and 
Test Methods," published on 31 January 2019, G/TBT/N/MEX/465 , 
G/TBT/N/MEX/465/Rev.1  (ID 67831) 
2.136.   The representative of the United States  provided the following statement. The United States 
remains highly concerned with the revi sed measure. Could Mexico provide a timeline for when it will 
respond to WTO Member comments? Could Mexico please provide an update on the status of this 
measure and an estimated timeframe of when the revised measure will be notified to the WTO? The 
United  States reiterates its request that Mexico consider allowing fatty acid analysis to be voluntary 
rather than mandatory. Currently, there are no internationally well -accepted biomarkers to 
differentiate milk fat from vegetable fat. Additionally, there are n o relevant Codex or other 
international standards available for this type of analysis. The United States is concerned this 
measure may conflict with the ongoing redrafting of the corresponding cheese standard. How will 
Mexico harmonize its update to the NO M-223 cheese standard with the NOM -223 cheese CAP notified 
to the WTO on 8 February 2022?  
2.137.   Once finalized, will implementation of the measure move forward based on Mexico's Quality 
Infrastructure Law or the law it replaced, the Federal Law on Metrology and Standardization? Could 
Mexico provide clarification on the different roles that each Ministry will play in the monitoring, 
compliance, and verification activities listed in the draft measure? Has Mexico considered extending 
its eventual timeline for implem entation of the measure to a period of 12 months or more? If Mexico 
proceeds with implementation of the current measure, the United States (Government and industry) 
would need at least one year to launch systems to comply. The United States urges Mexico to  
indefinitely delay implementation of the measure and consider less trade -restrictive alternatives as 
previously proposed by the US Government, other WTO Members, and industry stakeholders.  
2.138.   The representative of New Zealand  provided the following statement . New Zealand welcomes 
the opportunity to again speak in support of this specific trade concern raised by the United States. 
New Zealand considers that the conformity assessment procedures that Mexico has set out for 
cheese under NOM -223 are more trade res trictive than necessary, with some aspects of the 
conformity assessment procedure creating unnecessary obstacles to international trade and likely to 
cause difficulties for New Zealand exporters. We support the request for Mexico to consider less 
trade -restrictive alternatives to the measures. We look forward to receiving a response from Mexico 
to the concerns raised, and an update on the status of any revised version of the Conformity 
Assessment Procedure.  
2.139.   The representative of Australia  provided the follo wing statement. Australia would like to 
reiterate its concerns that Mexico's measure notified as G/TBT/N/MEX/465  and associated revision 
appears discriminatory and more trade restrictive than necessary. Australia recognizes the original 
objectives of the proposed measures and welco mes the review of the procedure in light of Mexico's 
international commitments. We look forward to receiving Mexico's reply to our comments on its 
revised notification. We kindly request an update for the release date of the new version of the 
procedure fo r public consultation.  
2.140.   In response, the representative of Mexico  provided the following statement. As mentioned 
at the previous meeting of the Technical Barriers to Trade Committee in July 2022, Mexico reaffirms 
its commitment to transparency under the Agr eement on Technical Barriers to Trade and the free 
trade agreements to which it is party and advises that the competent standard -setting authorities 
are currently in the process of analysing the comments received during the public consultation 
period. Once  the authorities have exhausted this process, the final version of the measure will be 
duly shared and notified to WTO Members.  
2.1.4.7   European Union - Chemical strategy for sustainability (implementation of the 
European Green Deal) (ID 69032) 
2.141.   The representative of Kenya  provided the following statement. The European Commission 
on 14  July 2021 adopted a set of intermediate proposals that aim to cut greenhouse gas emissions 
by 55% by 2030 as part of a broader European Green Deal (EGD). While the EGD is mainly an 
 
31 For previous statements follow the thread under ID 678 . 
32 For previous statements follow the thread under ID 690 . G/TBT/M/88  
 
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  internal EU policy instrument, its potential for global spill -overs are likely to have significant impacts 
on production and trade for developing countries. Kenya is therefore concerned that this measure 
has not been notified. Kenya is greatly concerned by o ne of the proposals that have been cited as 
one of the key deliverables of the European Green Deal policy that was enacted in 2020. This is the 
EU Proposal on Corporate Sustainability Due Diligence. Published on 23 February 2022, the EU 
proposal on Corpora te Sustainability Due Diligence poses significant barriers to trade between Kenya 
and the EU owing to the scope of its provisions. The proposal requires that EU companies work with 
exporters in identifying and preventing/mitigating adverse impacts of their  activities on human rights 
(child labour, exploitation of workers etc.) and on the environment (pollution, biodiversity loss etc.). 
The EU claims that the objective of the proposal is to foster sustainable and responsible corporate 
behavior throughout the  global value chains. Kenya's concern is premised on the fact that developing 
countries are already struggling to meet international standards, technical regulations and 
conformity assessment procedures necessary for international market access. Imposing a dditional 
sustainability requirements as prerequisites for market access will be burdensome (in both financial 
costs and technical capacities) to value chain actors across the developing world, including Kenya. 
There is also a further concern that these pr ivate standards are often developed without the input 
from the developing countries, yet they are expected to comply/implement them without any clear 
commitment for technical support. Kenya therefore welcomes a comprehensive dialogue with the 
EU and other Members of the WTO on this matter, prior to advancing to further stages in the 
development of this policy.  
2.142.   The representative of the Russian Federation  provided the following statement. As our 
concern remain unaddressed, the Russian Federation reiterates t he statements made during the 
previous meetings of the present Committee and expresses deep concern on the chemical strategy 
developed by the EU as an element of implementation of the European Green Deal. The strategy 
implies potential restriction and even  prohibition of materials that are classified as hazardous 
regardless of whether the scientific basis for that has been provided or not. We understand that the 
core legal act for classification of chemicals and substances of the EU is the CLP Regulation. 
Currently, this regulation allows to make strict classification decisions without sufficient scientific 
data or any other analysis in accordance with the precautionary principle. One recent example of 
this practice is cobalt classification under the 14th AT P to the EU CLP Regulation. Such approach can 
lead to unjustifiable prohibition of essential materials. We also note worryingly that one of the aims 
announced by the strategy is to "identify strategic dependencies " of the EU and "propose measures 
to reduce  these dependencies ". This aim is protectionist by nature and discriminative against 
imports.  
2.143.   We urge the EU to implement the strategy only to the extent compatible with its WTO 
obligations. Moreover, Mr. Chairman, it is regrettable that the EU have chosen  not to engage with 
WTO membership, specifically with Russia, on this issue as it has been refusing to respond to present 
concern for several meetings in a row. This situation is of systemic concern. Transparency is the 
important pillar of this organizatio n and provision of explanations on various measures and policies 
in this Committee is the part of the mechanism. Refusal to respond to the raised trade concerns is 
in stark contrast to the EU's rhetoric about the importance of transparency in this organiza tion. 
2.144.   In response, the representative of the European Union  provided the following statement. 
The European Commission would like to stress that the Chemical Strategy for Sustainability is not a 
technical regulation in the meaning of the TBT Agreement. It is only a communication document 
from the European commissio n addressed to the EU member States and stakeholders outlining 
future policy for the purpose of transparency. Therefore, we are not in a position to give substantive 
feedback on this specific trade concern.  
2.1.4.8   European Union - Draft EU Batteries Regulation (i mplementation of the European 
Green Deal), G/TBT/N/EU/775  (ID 68533) 
2.145.   The representative of China  provided the following statement. China supports the EU's 
efforts for better regulation of batteries and waste batteries. China would like to raise concerns as 
follows : Firstly, we would like to know the progress in formulating calculation methods for carbon 
footprint and recycled content by the EU side. And we would like the EU to allow participation in the 
above method -making process from other Members. Secondly, it is  recommended for the EU update 
timely the carbon footprint database and adopt data from non -EU institutions as necessary and 
 
33 For previous stateme nts follow the thread under ID 685 . G/TBT/M/88  
 
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  appropriate. Thirdly, we would like to remind the EU that the requirement on relevant technical 
documents may result in the disclos ure of commercial secrets. The required information such as the 
content of cobalt, nickel, lithium contained in batteries, and carbon emission date in the production 
process of electrolyte and isolation membrane, involves multiple core business secrets. To  disclose 
such information in the technical documents poses a risk of secret leakage. It is recommended to 
set relevant protection clauses or cancel the disclosure of the technical documents containing 
commercial secrets when the regulatory objectives coul d be satisfied otherwise  
2.146.   Fourthly, regarding point 3 of Article 9, it is recommended to phase out the non -rechargeable 
portable batteries in accordance with their types, for example, to phase out the non -rechargeable, 
non-lithium portable batteries of gene ral application. We believe that without safety issues and 
serious pollution, the elimination of a certain type of portable battery should be achieved by the 
market, technology development, and users, not by legislation. Finally, regarding the requirement 
for manufacturers' registration in articles 46 and 47, it is recommended to allow producers to register 
in only one EU member State, for example in the country of the importer, which is the main 
importation country, rather than in all EU member States. We suggest the EU consider establishing 
a single EU regulatory system where producers could identify one EU member State as the main 
target market and perform their procedural responsibility only once.  
2.147.   The representative of the Russian Federation  provided the  following statement. As our 
concern remain unaddressed, the Russian Federation reiterates the statements made during the 
previous meetings of the Committee on TBT with regard to the proposal for a Regulation of the 
European Parliament and of the Council c oncerning batteries and waste batteries. We appreciate 
efforts in the fields of environment protection and fighting climate change. However, we do believe 
that these shall be done respecting international obligations. Specifically, as stated previously by 
setting minimum level of recycled materials in the battery the draft regulation discriminates imported 
primary materials vis -à-vis domestically remanufactured, and aims to substitute imported primary 
metals for the like domestically recycled ones. We reite rate request to clarify if the European Union 
considered less trade restrictive measures to stimulate recycling of nickel, lithium, cobalt, copper 
and lead rather than such administrative measure as minimum level of recycled materials in the 
battery. If ye s, name the measures that the EU has considered and reasons why these measures 
haven't been employed or proposed for implementation.  
2.148.   Russia is also concerned with the lack of scientific data and international standards as a basis 
for proposed conditions fo r access to the EU market as well as material recovery targets for waste 
batteries. Many elements of the European Green Deal and implementing legal acts are of concern to 
us. One of the objectives of the Deal is import substitution which goes against spiri t of the WTO. We 
urge the EU to conduct its trade -related climate policy in compliance with the WTO rules. Finally, as 
the EU have chosen not to respond on present trade concern to Russia we note that this situation is 
of systemic concern. Transparency is the important pillar of this organization and provision of 
explanations on various measures and policies in this Committee is part of the transparency 
mechanism. Refusal to respond to the raised trade concerns is in stark contrast to the EU's rhetoric 
about the importance of transparency in this organization.  
2.149.   In response, the representative of the European Union  provided the following statement. 
The EU has taken good note of the points raised by the Chinese Delegation. In relation to the 
progress in formula ting calculation methods for carbon footprint and recycled content, we would like 
to inform you that the preparatory work for this is in the very early stages. The EU would like to 
reassure that such implementing and delegated acts that will be developed u nder the notified draft 
will involve consultation of stakeholders, though the exact way in which this will be done is to be 
determined in each case. Drafts of those implementing measures and delegated acts will be notified 
to the WTO in accordance with the  TBT Agreement. The application dates for some of the provisions 
in the notified draft are relatively soon. This is because significant developments in the battery sector 
are taking place in the near future. However, the EU would like to clarify that the i ndicated application 
dates are provisional, because it will depend on the time needed for the regulatory process to adopt 
the notified draft. In fact, it is clear that at least some of the application dates need to be reassessed, 
because the regulatory pro cess is still ongoing. The European Parliament and the Council have 
concluded their respective positions in March this year. The aim is to conclude this process soon.  G/TBT/M/88  
 
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  2.1.4.9   United States - Protecting Against National Security Threats to the 
Communications Supply  Chain through the Equipment Authorization Program and the 
Competitive Bidding Program, G/TBT/N/USA/1771  (ID 71434) 
2.150.   The representative of China  provided the following statement. The draft violates the WTO 
principles of non -discrimination and transparency as it only targets five C hinese enterprises and 
identifies Chinese products as security threats, which is not based on technical standards. China 
would like the US to inform the progress in making the relevant rules as soon as possible. For the 
newly added 47 CFR 2.903, it is reco mmended to revoke it. This part prohibits the authorization of 
certain telecommunications equipment and services under provision 47 CFR 1.50002, but 47 CFR 
1.50002 lists only five Chinese companies, which violates the non -discriminatory principle. For 
Section III. A of the draft regulations, it is recommended to provide technical standards for judging 
the national safety threats and to authorize the products that comply with the safety technical 
standards for national safety. The draft regulations prohibit the authorization of certain 
telecommunications equipment and services under provision 47 CFR 1.50002, on account of national 
security threats. We believe that identifying products of Chinese companies as security threats 
without open technical standards c onstitutes a violation of the transparency principle of the TBT 
Agreement. It is recommended to provide such standards and notify WTO Members, and, provide 
opportunities for Members to make comments.  
2.151.   Section III.A.3 of the draft regulations seeks comments on whether to revoke any of the 
authorizations that have been previously granted for "covered " equipment on the Covered List (47 
CFR 1.50002). It is recommended not to revoke the authorizations. The equipment authorizations 
that have been previously grante d are obtained strictly in accordance with the then -effective 
regulations, through the process of TCB certification or SDOC by the FCC. There is no violation of 
the situations mentioned in provision 2.939 of section III.A.3.  
2.152.   In response, the representative  of the United States  provided the following statement. The 
United States notified the proposed rules, "Protecting Against National Security Threats to the 
Communications Supply Chain Through the Equipment Authorization Program and the Competitive 
Bidding Program, " to the WTO on 3 September 2021. This action is a Notice of Proposed Rulemaking 
(NPRM) (ET Docket No. 21 -232) by the United States Federal Communications Commission (FCC), 
adopted on 17 June 2021, in which the FCC proposes to revise rules related to its equipment 
authorization processes to prohibit authorization of any "covered" equipment on the recently 
established Covered List, included in PUBLIC LAW 116 –124 Secure and Trusted Communications 
Networks Act of 2019, enacted by U.S. Congress 12 March  2020. The FCC accepted formal comments 
on the Equipment Authorization Notice of Proposed Rulemaking until 18 October 2021, and China's 
comments were submitted on 18 September 2021. In total, the FCC has received nearly 250 
comments, including from China. All of the comments are available to the public and can be found 
on the FCC's website. United States appreciates China for its comments. The final rule will include 
information on all substantive comments received, and how the comments were taken into acco unt. 
Information on any rule changes - once they are publicly available - will be notified to the WTO as 
an addendum to the original notification.  
2.1.4.10   China - National Standard of the P.R.C., Lithium Ion Cells and Batteries Used in 
Portable Electronic Equipmen ts - Safety Technical Specification, G/TBT/N/CHN/1576  (ID 
70635) 
2.153.   The representative of the Republic of Korea  provided the following statement. The Republic 
of Korea fully understands the importance for China to amend the "National Standard of the P.R.C., 
Lithium Ion Cells and Bat teries Used in Portable Electronic Equipments - Safety Technical 
Specification (GB 31241)" in order to protect consumers, and Korean companies are making efforts 
to faithfully comply with the standard. However, the Korean industry has continued to voice 
difficulties in regulatory compliance, so Korea would like to reiterate its concerns raised at the last 
July 2022 WTO TBT Committee meeting. According to the document of opinions published on the 
Chinese government website on 23 September 2022 as "General Of fice of the State Council issuance 
[2022] No. 31", lithium -ion batteries and battery packs have been included in the list of products 
subject to compulsory certification management. Korea would like to enquire China whether or not 
this compulsory certifica tion for lithium -ion batteries and battery packs will be implemented under 
 
34 For previous statements follow the thread under ID 714 . 
35 For previous statements follow the thread under ID 706 . G/TBT/M/88  
 
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  the Draft for Approval of GB 31241:20XX. It is concerned that the Draft's marking requirements in 
clause 5.3.1 are not harmonized with the relevant international standard (IEC 61960 -3). Accordingly, 
should the compulsory certification follow the GB 31241 Draft for Approval, manufacturers will be 
forced to replace production facilities and rework existing products only for exports to China, which 
will be quite costly and time -consumin g, laying an excessive burden on the relevant industry.  
2.154.   If China considers that cell body marking is necessary for product tracking and identification 
purposes, Korea requests that China consider changing the marking requirements for all cells to be 
the sa me as the requirements for cells with a maximum surface area of below 4cm2 (as in Draft 
clause 5.3.1). This way, only the minimum necessary information (such as polarity) can be marked 
on the cell body, while all the rest of the information (rated capacity , date of manufacture, batch 
number, etc.) can be indicated with a Manufacturer's Code, which is elaborated by the means of 
minimum packaging or battery specification sheet. In the event that the Draft for Approval is to be 
implemented as is, Korea request s that a sufficient grace period of more than one year be given in 
consideration of the time required for the industry to adapt to the new regulation. Korea would also 
like to request that China provide information, if available, regarding the compulsory c ertification's 
date of entry into force, the implementation procedures for compliance and the relevant national 
standards.  
2.155.   In response, the representative of China  provided the following statement. The identification 
is very important for the safe use of c ells and batteries. As an important component of the battery, 
without necessary identification information, cells cannot be traced or identified effectively. Cells 
without identification have caused much confusion in market regulation in recent years. Ther efore, 
through investigation and extensive consultation during the formulation, GB 31241 -20xx proposed 
relevant requirements for cell body identification. China will not consider deleting exceptions.  
2.1.4.11   European Union - Proposal for a regulation of the Europe an Parliament and the 
Council laying down harmonised rules on artificial intelligence (Artificial intelligence act) 
and amending certain union legislative acts (ID 73636) 
2.156.   The representative of China  provided the following statement. China supports the EU's  
governance on artificial intelligence, however, from the perspective of not creating unnecessary 
trade barriers, China would like to raise concerns as follows : For Article 43.3, we would like to stress 
that it is not appropriate to determine whether an AI  system needs a third -party Notified Body to 
participate in the conformity assessment according to the requirement in Annex II A. For example, 
for radio equipment defined as AI systems, even if the provider has used all the harmonized 
standards related to AI regulations, but when the radio frequency standards relating to their products 
are not harmonized, a third -party Notified Body is still required in accordance with the RED Directive. 
It is recommended that the conformity assessment for AI systems in App endix II A could be in line 
with article 43.1. For article 71, we would like to stress, the penalties and the fines should be 
proportionate to the actual performance. Article 71 stipulates a fine of up to 2% of its total worldwide 
annual turnover, which we  believe is higher than is appropriate. China recommends reassessing and 
resetting the penalties.  
2.157.   For article 5.2 in Annex VII, it is recommended to clarify the scope of the "necessary 
information " to be shared by the provider, for the sake of providers' l egal certainty. Finally, it is 
recommended to extend the transition period to 48 months. Providers need to wait for the 
publication of the harmonized standards before they can carry out the ex -ante conformity 
assessment mentioned in Title II, Chapter 2. It  usually takes more than 36 months for standards 
bodies to lay down new standards, and another 12 months for providers to adjust products and 
systems, conduct conformity assessments and prepare all required documentation. The given 
transition period of 24 months in this regulation is not enough.  
2.158.   In response, the representative of the European Union  provided the following statement.  
The EU regrets that China did not make its statement on this trade concern available on e -Agenda 
ahead of this meeting, and th erefore the EU cannot provide a reply to concerns expressed here 
today. The EU therefore refers to its previous statements on this measure. The EU would like to 
thank China for their comments on proposed Artificial Intelligence Act. On 8 July 2022, the EU 
provided a detailed written response to the comments received. As concerns expressed here today 
 
36 For previous stateme nts follow the thread under ID 736 . G/TBT/M/88  
 
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  represent a repetition of concerns expressed by China in its comments to notification 
G/TBT/N/EU/850 , the EU makes reference to its replies provided on 8 July 2022.  
2.1.4.12   China - Recommended Nat ional Standard (GB/T) for Office Devices (Information 
security technology – Security specification for office devices) (ID 76137) 
2.159.   The representative of Japan  provided the following statement. Japan raised concerns 
regarding China's National Standard on off ice devices including multifunction peripherals and 
printers at the last TRIMs Committee meeting and the last Market Access Committee meeting. At 
the Market Access Committee meeting, China responded that China has no plans to revise the 
Recommended Nationa l Standards related to printers and copiers in the near future. However, as 
posted on the website of the National Information Security Standardization Technical Committee, 
TC260, on 2 November, it was revealed that the Technical Committee is in the process  of drafting a 
revision to the Recommended National Standards. Japan is confused by this inconsistency with 
China's statement at the TRIMs Committee meeting and the Market Access Committee meeting. 
Japan requests China to share its intention on the revisio n of national standards, and the contents 
of the draft national standard, including (i) the coverage, especially the definition of "critical 
information infrastructure operators ", (ii) the requirement to design and produce office devices and 
their componen ts in China and (iii) the requirement to provide information to verify that they are 
designed and produced in China.  
2.160.   As pointed out at the last TBT Committee meeting and other WTO meetings, regarding office 
devices procured by critical information infrastr ucture operators, in case the national standard 
requires on a de -facto basis that office devices and their components are developed, designed, 
produced and manufactured in China and information to prove office devices and their components 
are done so is pr ovided disclosed, there are concerns on (i) discriminatory treatment of foreign 
products, (ii) creating unnecessary obstacles to international trade, and (iii) causing forced 
technology transfer. Therefore, the national standard would be inconsistent with TBT Agreement 
Articles 2.1, 2.2 and 5.1.2, GATT Article III.4, and China's WTO accession protocol Article 7.3, etc. 
Japan strongly requests China not to amend the national standards, or to establish systems or 
guidelines relating to them, in a form contain ing such matters of concern. Besides, Japan strongly 
urges China not to take the same or similar measures in other industrial sectors or products.  
2.161.   The representative of the European Union  provided the following statement. In its reply to 
the STC, initially  raised at the July TBT Committee, China noted that the recommended national 
standard was not being revised but if it were, public opinion would be solicited. However, now it 
seems that the standard is being revised by the National Information Security Sta ndardisation 
Technical Committee (TC260). Based on the information received about the revised requirements, 
if enacted, they would rule out the possibility for overseas office device providers to participate in 
government procurement in China, as most of t heir products rely heavily on overseas components. 
The EU would like to emphasise that all office equipment cannot be classified as critical information 
infrastructure. Indeed, this highlights even more the urgency of having a clear and specific definition  
of critical information infrastructure operator. The EU also urges China not to take similar measures 
in other sectors or products.  
2.162.   In response, the representative of China  provided the following statement. Regarding the 
revision of the recommended national standards related to printers and copiers concerned by Japan 
and the EU, the administrative department for standardization under the State Council is responsible 
for orga nizing professional examination and assessment institutions of national standards to 
evaluate the national standard projects. For the proposed national standard project approved after 
the examination and assessment, the administrative department for standa rdization will publish a 
notice of project approval through the National Public Service Platform for Standards Information. 
During the process of the revision, China will solicit public comments, and all interested Members 
including Japan will have an oppo rtunity to make comments at that time. Regarding the information 
provided by Japan, I would like to say that at the last Committee meeting, Japan raised this issue 
for the first time without early notice in advance and China made a written response to Japa nese 
colleague after that meeting. It is a bit of a surprise that  Japan  continues to raise this issue at TRIMs 
Committee meeting, and also Market Access Committee meeting. China has always been kept open 
and transparent in the process of establishment and revision of national standards. This national 
standard  is at a very early stage, and we would like to contribute to bilateral consultations with the 
 
37 For previous statements follow the thread under ID 761 . G/TBT/M/88  
 
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  two Members. Regarding the information mentioned  by Japan, it would be very helpful if Japan  could 
provide written comments to us and provide  more detailed  information on the text you have got.  
2.1.4.13   Canada - Proposed Prohibition of Certain Toxic Substances Regulations, 2022, 
G/TBT/N/CAN/673  (ID 75338) 
2.163.   The representative of Japan  provided the following statement. We appreciate Canada's 
comments on our opinions after the last TBT Committee. However, Japan continues to have the 
following concerns regarding the proposed DBDPE restriction in the Proposed Prohibition of Certain 
Toxic Substa nces Regulations, 2022. DBDPE is widely used in electrical and electronic equipment, 
automobiles, aircraft, medical equipment, industrial equipment, social infrastructure equipment, 
agricultural machinery, industrial machinery, construction machinery and i ndustrial vehicles. DBDPE 
is an alternative to decaBDE, a globally banned brominated flame retardant, and is not restricted by 
international conventions or other jurisdictions. In addition, since there is no equivalent flame 
retardant for many applications  that can be used as a substitute for DBDPE currently, we are 
concerned that there will likely be significant and serious impacts on the trade and distribution of 
the above equipment in the case that the use of DBDPE is prohibited. We understand that the 
Canadian government seems to be considering the introduction of the regulations carefully. 
However, due to potential impacts on important instruments that support industries and citizens' 
lives in Canada such as medical equipment, industrial equipment and t ransport equipment, Canada 
should be particularly cautious about considering alternatives to DBDPE, including safety 
assessments and establishing a grace period for implementation, with additional hearings from 
stakeholders. It should also be noted that th e risk of exposure to humans and the environment is 
limited because these devices are usually collected under strict control after use and properly 
recycled or disposed of.  
2.164.   Canada cited the protection of endangered whales and belugas as the main reason for  
regulating DBDPE. Although we understand the objectives of the policy, Japanese industry reports 
that DBDPE contained in articles poses a very low risk of adverse effects on humans and the 
environment, including these endangered species. Therefore, in ord er to ensure that the proposed 
DBDPE restriction is not more trade restrictive than necessary to achieve its legitimate objectives, 
Japan would like to request that Canada undertake the following: (i) conduct a more thorough risk 
assessment on the effects of DBDPE contained in articles on human health or the environment, while 
taking into account the consistency with results of risk assessments from other countries and 
regions; (ii) conduct a realistic feasibility study on alternatives to DBDPE; and (iii) b ased on the risk 
assessment and the feasibility study, consider whether to introduce the DBDPE restriction, and the 
introduction schedule including a grace period.  
2.165.   In response, the representative of Canada  provided the following statement. In 2019, 
Canada published the screening assessment for Decabromodiphenyl ethane (DBDPE) , which 
concluded that there is a risk of harm to the environment due to the persistence and widespread 
occurrence of DBDPE in the environment along with the potential for bioaccumulat ion and toxicity of 
its transformation products. On 14 May 2022, Canada published in Part I of the Canada Gazette, the 
Proposed Prohibition of Certain Toxic Substances Regulations, 2022. Publication of the proposed 
Regulations opened a 75 -day comment perio d for stakeholders. The measure was notified to the 
WTO TBT Committee on 18 May. We appreciate the comments received by Japan and other 
Members. Canada is carefully reviewing and analysing all public comments received during the 
comment period, in consider ation for the development of the final regulations. Currently, in Canada, 
there are some controls on DBDPE through the New Substances Notifications Regulations (Chemicals 
and Polymers). The proposed Regulations would introduce restrictions on the manufactu re, use, sale 
and import of DBDPE.  
2.166.   The proposed regulation aims to reduce the risk of toxic substances entering the Canadian 
environment, contributing to the protection of Canada's environment and wildlife. The proposed 
regulation would repeal and replace the Prohibition of Certain Toxic Substances Regulations, 2012, 
which prohibit the manufacture, use, sale offer for sale and import of certain toxic substances and 
products containing them, with a limited number of exemptions. It is expected that the propos ed 
Regulations will result in an improvement in environmental quality by contributing to a reduction of 
these substances and ultimately their release to the environment over time. For example, the 
proposed Regulations would help the Government in meeting i ts commitments under the Whales 
 
38 For previous statements follow the thread under ID 753 . G/TBT/M/88  
 
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  Initiative by addressing threats to the Southern Resident Killer Whale and St. Lawrence Estuary 
Beluga, which are both endangered species. The preservation of both species is valuable to Canadian 
society, particularly Indige nous people who have cultural and spiritual connections to these species. 
Specific exemptions, such as for parts used in the automotive, aerospace, and electrical and 
electronic sectors, are proposed for DBDPE. These exemptions take into account socio -economic 
factors, the demonstrated absence of suitable alternatives, and consideration of the international 
context and risks to the environment, and are time limited in most cases. While a number of specific 
exemptions have been proposed, a permit process pro vides an additional mechanism to address 
unforeseen challenges. The Regulations would not apply to a manufactured item, such as wires and 
cables containing DBPDE, that is in transit through Canada. The proposed Regulations also include 
administrative chang es to simplify the regulatory text and to further clarify the intent of certain 
sections of the Regulations. Again, we appreciate Japan's interests and comments on this proposed 
measure and would welcome the opportunity to address additional questions or i ssues bilaterally.  
2.1.4.14   China - Measures for the Administration of Data Security in the Field of Industrial 
and Information Technology Sectors (For Trial Implementation) (ID 75139) 
2.167.   The representative of Japan  provided the following statement. Japan has concerns  about the 
Measures for the Administration of Data Security in the Field of Industrial and Information 
Technology Sectors, especially referring to that the unclear relationships still exist among many 
articles of the measures, the Cybersecurity Act, which was open for public comment in this 
September and the related provisions of the Cybersecurity Act. The Japanese government has 
already submitted comments including this point on the second public consultation in February 2022. 
Moreover, the definitions of "general data", "critical data", and "core data" do not provide objective 
and specific criteria for classification. Japanese industry has voiced concerns, and we would like to 
ask about the status of the measures. In addition, although Article 7 of the mea sures stipulates that 
the Ministry of Industry and Information Technology (MIIT) is to formulate a detailed inventory of 
"critical data" and "core data", depending on the specifics of the detailed inventory and related 
regulations, it may have a significan t impact on the businesses involved in the industrial information 
field. Therefore, Japan would like to request that China utilize transparent procedures in formulating 
the detailed inventory, so that the opinions of stakeholders including foreign companie s can be 
widely heard and reflected, and ensure that undue burden is not placed on business operators.  
2.168.   In response, the representative of China  provided the following statement. The Measures for 
Data Security Management in the Fields of Industry and ICT, w hich are now under review, are for 
better implementation of the Data Security Law of China. Combining the characteristics of industry 
and ICT, the policy has refined the administrative requirements for data classification and gradation, 
security management  of important data and core data, data monitoring, early warning, and 
evaluation in relevant fields, and clarified the requirements of data life cycle security protection. The 
policy will provide more operational guidance for data processors in industry an d ICT fields to fulfill 
their data security protection obligation.  
2.1.4.15   China - Key Points and Judgment Principles of GMP Inspection for Cosmetics; 
Safety and Technical Standards for Cosmetics (2022); Technical Guidelines for Children's 
Cosmetics, G/TBT/N/CHN/1673 ; G/TBT/N/CHN/1674  (ID 74940) 
2.169.   The representat ive of the United States  provided the following statement. At the July TBT 
Committee meeting, the United States raised concerns with China's recently notified CSAR 
measures, the Key Points and Judgment Principles of GMP Inspection for Cosmetics ( "GMP Inspe ction 
Points ") (G/TBT/N/ CHN/1673 ) and the 2022 Safety and Technical Standards for Cosmetics 
(G/TBT/N/CHN/1674 ), as well as the not -notified Technical Guidelines for Children's Cosmetics. 
Regarding the latter, we note that despite the measure's title, we requested notification of the 
Technical Guidelines  because they appear to include new requirements for children's cosmetics. As 
China was unable to provide a response in the last meeting and has yet to address prior US 
comments on these concerns, we bring this STC before the Committee again. In July, the United 
States asked that China: ensure sufficient time to take into account comments received on the WTO 
notifications, prior to the GMP Inspection Points' adoption; delay implementation of the GMP 
Inspection Points, giving industry at least two years to a dapt their products and methods of 
production; and clarify whether there will be flexibility in implementation, such as allowing 
 
39 For previous statements follow the thread under ID 751 . 
40 For previous statements follow the thread under ID 749 . G/TBT/M/88  
 
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  companies to utilize international standards, if appropriate, to demonstrate conformity with China's 
requirements.  
2.170.   It appears t hat China has yet to publish the finalized GMP Inspection Points; the Safety and 
Technical Standards for Cosmetics and the Technical Standards for Children's Cosmetics. We also 
note China opened a second domestic public consultation for potential updates t o the Safety and 
Technical Standards for Cosmetics, without having clarified the status of the 2022 version it notified 
to the TBT Committee in April. Could China please provide an update as to the status of these three 
measures, and in particular, clarify  its plans for implementation of the Safety and Technical 
Standards for Cosmetics? In regard to new measures notified since July, we thank China for notifying 
the Provisions for the Supervision of Cosmetics Sampling and Testing ( G/TBT/N/CHN/1682 ) and the 
Provisions for the Superv ision of Cosmetics Online Distribution ( G/TBT/N/CHN/1699 ). We note the 
concern of US industry that the Provisions for the Supervision of Cosmetics Sampling and Testing 
offer limited options to address any perceived defects in a way that is appropriate to the potential 
risk to con sumer health and safety. We ask China to consider the 12 September written comments 
submitted by the United States and US industry, on the Sampling and Testing measure. We note 
that companies need sufficient time to respond to test findings as to the safet y of their products and 
the ability to engage with both NMPA and its agents on options for remediation.  
2.171.   Are China's microbiological testing limits in accordance with international standards? If not, 
we would also ask that China, in line with its commitment s under Article 2.9.3 of the TBT Agreement, 
identify how and why these limits deviate from international standards. As noted in prior comments 
by the United States and US industry, we maintain concerns that China does not identify when new 
cosmetics standa rds, including those standards included in the update to the 2022 Safety and 
Technical Standards for Cosmetics ( G/TBT/N/CHN/1674 ), are not in accordance with international 
standards. We thank China for its consideration and look forward to responses to our questions.  
2.172.   In response,  the representative of China  provided the following statement. The Key Points 
and Judgment Principles of GMP inspection for cosmetics are formulated for the purpose of regulating 
the cosmetic production licence, supervision, and inspection, and guiding the  cosmetic registrants 
and entrusted production enterprises in implementing the "Cosmetic Production Quality Management 
Standard". There are no new obligations for the cosmetic registrants and entrusted production 
enterprises. As for the retention samples o f imported cosmetics, overseas cosmetics registrants shall 
retain samples of each batch of products imported to China after 1 January 2022. The samples and 
records shall be kept by the responsible person within China. If the same batch of products is 
impor ted from China more than once, the sample shall be retained at least once at the time of the 
first importation. At present, safety and technical standards for cosmetics have been open to the 
public for comments. The revision process has fully considered al l kinds of relevant regulations and 
standards of cosmetics, including those of ISO standards based on the actual situation of China's 
cosmetics industry and supervision.  
2.173.   In order to strengthen the technical guidance for the research and development of chil dren's 
cosmetics products, and promote better regulation on the registration of children's cosmetics, China 
has issued the Technical Guidelines for Cosmetics based on existing regulations on cosmetics, taking 
into consideration public opinions. In the draf ting process, we stick to the principle of "openness, 
transparency, and extensive participation", take into account relevant technical guidelines at home 
and abroad, solicit opinions from industry associations, and make corresponding revisions for 
improvem ents. In order to increase operability and provide technical guidance for the research and 
development of enterprises, the guidelines integrate and clarify the requirements in the Regulations 
and supporting legal documents on children's cosmetics, but do n ot add new requirements.  
2.1.4.16   European Union - Hazard -based approach to plant protection products and 
setting of import tolerances, G/SPS/N/EU/166 , G/SPS/N/EU/166/Add .1, 
G/SPS/N/EU/263 , G/TBT/N/EU/383 , G/TBT/N/EU/383/Add.1 , G/TBT/N/EU/384 , 
G/TBT/N/EU/384/Add.1 , G/TBT/N/EU/495  (ID 39341) 
2.174.   The representative of Australia  provided the following statement. Australia remains 
concerned about the significant uncertainty surrounding the mechanisms for setting import 
tolerances for substances falling under the hazard cut -off criteria. We would welcome the release by 
the EU of guidance material on the procedures for handling requests for import tolerances. Australia 
 
41 For previous statements follow the thread under ID 393 . G/TBT/M/88  
 
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  reiterates its position from previous meetings about the importance of adopting a risk -based 
approach for regulating plant protection products rather than con sidering only the potential for harm 
due to the intrinsic properties of a chemical. We remain available to discuss our approach to pesticide 
regulation with the EU and look forward to continued and constructive engagement on this issue, 
including in the SP S Committee.  
2.175.   The representative  of Costa Rica  provided the following statement. Costa Rica is concerned 
about the hazard -based approach adopted by the European Union given that, under the obligations 
of the multilateral system, all technical requirements m ust be aligned with the international 
reference standard or a risk assessment that provides the scientific basis for the measure. Costa 
Rica reiterates its request to the European Union to ensure that its regulations are based on risk 
assessments, by apply ing criteria supported by sufficient scientific evidence, in line with the 
obligations under the TBT Agreement.  
2.176.   The representative of Ecuador  provided the following statement. Once again, Ecuador 
reiterates its support for the trade concern raised by Costa  Rica and Australia and shares the points 
and doubts set out  in the statements of previous speakers.  Ecuador shares the genuine interest in 
the importance of protecting human and environmental health; however, we consider that regulatory 
decisions adopted on the basis of hazard -based criteria are not consistent with international risk -
assessment practice.  Ecuador urges the EU to take into consideration the relevant scientific 
information emanating from international specialized agencies recognized by the WT O, such as the 
Codex Alimentarius, which has relevant information on pesticides. This, in order not to be more 
trade -restrictive than necessary to fulfil a legitimate objective, in accordance with Article 2.2 of the 
TBT Agreement.  Lastly, Ecuador again enj oins the European Union that, in cases where scientific 
information is lacking, the EFSA not make a recommendation on the MRL, since decisions on 
regulatory measures must be based on conclusive risk analyses that offer real conditions for health 
protection  so as to avoid becoming a technical barrier to trade.  
2.177.   The representative of Brazil  provided the following statement. Brazil would like to refer to 
its previous statements regarding STC 393. We emphasize that regulations on endocrine disruptors 
should be e stablished according to sound scientific principles, taking all available data into 
consideration. Serious evaluations must be able to separate chemicals that have the potential to 
cause harm due to their endocrine mode of action from those substances that  do not pose a threat 
to human health. A solid risk analysis, consistent with Codex guidelines, is important to ensure 
transparency and predictability in the regulatory processes regarding plant protection products and 
MRLs. In the last TBT Committee meeti ng, EU mentioned that granting import tolerance would make 
its regulation adherent to the risk analysis principle. This very principle is indeed one of the issues 
that has been raised in this STC over recent years. EU concedes emergency authorization to it s 
national member States and deny import tolerances to third countries where the same conditions 
prevail. Brazil believes that the European approach to limit the use of pesticides is more trade -
restrictive than necessary to fulfill its legitimate objective s under the TBT Agreement. It also 
disregards risk analyses in the setting of regulatory measures that may have a serious impact on 
trade.  
2.178.   The representative of Canada  provided the following statement. Canada would like to take 
this opportunity to once aga in echo the concerns raised by many other Members regarding the 
European Union's (EU) hazard -based regulation for active substances in plant protection products 
and the setting of import tolerances. We encourage the EU to take an approach which does not 
unnecessarily limit the availability of all crop protection tools for growers. Regulatory decisions based 
on assessments of both hazards and risks for all active substances are the best means to achieve 
the right balance between grower and consumer safety on  one hand and food security and reduced 
waste on the other. Canada does not favour or promote the use of any one production method over 
another and we share the objective of ensuring that pesticides are used only as necessary. We have 
in place an effective  regulatory regime to monitor the safe use of chemical solutions when needed, 
including clear labelling requirements.  
2.179.   Farmers need to have access to a wide range of effective and affordable plant protection 
products, including both chemical and biological options, to ensure plant health and minimal waste. 
Using integrated pest management approaches, we support farmers in their own assessment of what 
is needed according to growing conditions, market demand and other factors. Canada's rigorous 
regulatory requ irements, including scientific assessments and monitoring programmes, ensure the 
health and safety of consumers where pesticide residues can be a factor, as well the health of the G/TBT/M/88  
 
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  environment. The EU has stated that it will be changing how requests for imp ort tolerances are 
established in the context of their current policy objectives, including the hazard -based cut off 
criteria and other (unspecified) considerations. Canadian growers and exporters have yet to be 
convinced of the real -world feasibility, com mercial viability and compliance with international 
obligations of the EU's proposed approach for setting import tolerances when a plant protection 
product has met the hazard -based cut -off criteria. Finally, Canada once again requests that the EU 
consider maintaining MRLs for substances that do not pose unacceptable dietary risks and import 
tolerances be authorized based on dietary risk alone. We recognize that a dietary risk assessment 
as part of the re -authorization process would likely be needed, regardl ess of the results of the hazard 
screen.  
2.180.   The representative of Guatemala  provided the following statement. Guatemala remains 
concerned about the EU's approach to the precautionary principle, without a risk analysis that 
includes risk assessment, risk manag ement and risk communication. This categorization means that 
regulations on "endocrine disruptors" must be based on sound scientific principles. Risk analysis 
consistent with Codex guidelines requires that chemicals be considered at supported risk levels. The 
application of a near -zero tolerance in MRLs without a supported scientific basis is considered 
potentially more trade restrictive than necessary to fulfil legitimate objectives as envisaged in the 
TBT Agreement. Agricultural producers and exporters in  developing countries with tropical climates 
are concerned about this new decision because access to active substances is subject to climatic 
conditions, safe use and good practice measures, which guarantee plant health. These substances 
are used due to di fferences in conditions, distance and transport of agricultural products in order to 
preserve their safety.  
2.181.   The representative of Argentina  provided the following statement. Argentina once again 
reiterates its concern regarding this matter and stresses the importance of ensuring that all Members 
implement measures based on risk assessments, taking account of the risk assessment techniques 
developed by international reference bodies. The latter include the principles for establishing 
pesticide MRLs, as well as the many risk analyses that, over the decades, the Codex Alimentarius 
has conducted to ensure safety in terms of MRL recommendations for  different substances and crops. 
Argentina joins the other delegations and reiterates its request to the European Union to ensure that 
the implementation of its regulations is based on the use of risk assessments through the application 
of criteria support ed by sufficient scientific evidence, in line with the commitments established in the 
TBT Agreement.  
2.182.   The representative of Uruguay  provided the following statement. We support the comments 
made by the preceding Members and reiterate our systematic trade concern relating to the European 
Union's use of a hazard -based approach, instead of an approach based on comprehensive scientific 
risk assessments, when adopting regulatory decisions concerning the authorization of active 
substances used i n plant protection products, and when setting import tolerance levels for 
substances that fall below the cut -off criteria in Regulation No. 1107/2009.  We wish to once again 
emphasize the need to base such determinations on conclusive scientific evidence, g athered from 
an assessment of actual risks, to avoid the withdrawal, despite their safe use, of certain active 
substances that continue to be important components of the pest -management system. This is 
because an approach based on hazard rather than actual  risk may have negative and 
disproportionate impacts on production, thereby contributing little or nothing to the stated aim of 
protecting public health.  Uruguay continues to support any multilateral work undertaken by the 
Codex Alimentarius to develop a h armonized, risk -based approach to the treatment of plant 
protection products that would ensure the protection of health, while also facilitating international 
trade in food products. In the meantime, we once again call on the European Union to listen to an d 
address the concerns expressed by many Members, and to reconsider its regulatory approach with 
a view to preventing the unjustified proliferation of barriers to international trade in agricultural 
products and potential socioeconomic consequences of such  an approach for other Members, in 
particular developing and least developed countries.  
2.183.   The representative of Paraguay  provided the following statement. Paraguay reiterates its 
position and refers to its previous statements, while stressing the importance of adopting a scientific 
approach to the regulation of phytosanitary products based on the risk and not just on the hazard 
arising from the intrinsic properties of a chemical.  
2.184.   In this regard, Paraguay once again requests that the European Union take into c onsideration 
information on pesticides provided by the specialized agencies recognized by the WTO, such as the G/TBT/M/88  
 
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  Codex Alimentarius; reconsider its approach; base its decisions on conclusive scientific evidence and 
real risk weightings, in accordance with in ternational standards and principles; ensure import 
tolerances and, where necessary, provide sufficient transitional periods.  
2.185.   The representative of Kenya  provided the following statement. The European Commission 
has notified on the hazard -based approach to  plant protection products and setting of import 
tolerances.  A risk-based approach  would involve establishment and adoption of mechanisms for the 
evaluation of risks on the basis of the probability of their occurrence and the extent of any resulting 
damage  together with the subsequent derivation of suitable measures. This is the most preferred 
approach/best global practice. In a hazard -based system , the presence of a potentially harmful agent 
at a detectable level in food is used as a basis for legislation and/or risk management action. 
Adoption of the hazard -based system by the EU has the potential to create unnecessary barriers to 
trade. Kenya wishes to support the other delegations that have raised this issue, since the Measure 
is deemed to be more trade restrictive than necessary contrary to Article 2.2 of the TBT Agreement.  
2.186.   The representative of Chile provided the following statement. The delegation of Chile  
reiterates the position it expressed in previous meetings of this Committee on the importance of 
adopting a scientific and risk -based approach to regulating phytosanitary products, instead of only 
considering the hazardousness of agrochemical products, given the importance of this sector to 
Chilean exports.  
2.187.   The representative of El Salvador  provided t he following statement. There is no question  
that El Salvador shares concerns about protecting the environment. However, technical 
requirements must respond to an international standard and be based on scientific evidence, beyond 
a mere risk assessment, so that applying them does not constitute an unjustified restriction of trade. 
We therefore share the concerns expressed by other delegations on the focus of this measure and 
we will continue to monitor this issue.  
2.188.   In response, the representati ve of the European Union  provided the following statement. 
The European Union thanks WTO Members for their interest in the ongoing work in the EU on 
identifying endocrine disruptors for plant protection products. The EU reiterates that the scientific 
criteria to identify endocrine disruptors for plant protection products based on the WHO definition 
are applicable since the 10 November 2018 onwards and included in Commission Regulation (EU) 
No 2018/605.42 This is complemented by a guideline from the European  Food Safety Authority 
(EFSA) and the European Chemicals Agency (ECHA), providing more details on how to interpret 
these criteria.43 We are aware of general concerns on the EU policy on plant protection products for 
the definition of scientific criteria to  identify endocrine disruptors and on the establishment of import 
tolerances for substances not authorized in the EU, due to the so -called "cut-off" criteria in 
Regulation (EC) No 1107/200944 on plant protection products. As previously explained, the Europ ean 
Union decided to follow the procedures of Regulation (EC) No 396/2005 for the management of 
import tolerance requests concerning active substances falling under these cut -off criteria, which 
include a risk assessment by an Evaluating EU member State an d a scientific opinion by the European 
Food Safety Authority (EFSA). The granting of the import tolerance is then considered in line with 
risk analysis principles on a case -by-case basis and taking into account all relevant factors. During 
the thematic ses sion on Trade Facilitating Approaches to Pesticide MRLs, in the margins of the SPS 
Committee of 22 March 2022, the EU provided an overview of the methodology used in the EU for 
pesticide residues risk assessment.45 The EU reiterates its commitment to act i n full transparency 
and keep Members duly informed about further developments.  
2.1.4.17   China - Cybersecurity Law (ID 52646) 
2.189.   The representative of Canada  provided the following statement. Canada would like to refer 
to its statements at previous TBT Committees and c ontinues to have significant concerns with China's 
 
42 Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 
1107/2009 by setting out scientific criteria for the determination of endocrine disrupting pr operties. OJ L 101, 
20.4.2018, p. 33.  
43 https://doi.org/10.2903/j.efsa.2018.5311   
44 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 
concerning the placin g of plant protection products on the market and repealing Council Directives  
79/117/EEC and 91/414/EEC. OJ L 309 24.11.2009, p. 1.  
45 https://www.wto.org/english/tratop_ e/sps_e/thematicsession220322_e.htm   
46 For previous statements follow the thread under ID 526 . G/TBT/M/88  
 
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  suite of cybersecurity and cryptography/encryption laws and related implementing regulations. 
Canada would also like to reiterate its concerns with the multiplication of implementing measures, 
which create s confusion and complicates businesses' ability to comply with all of them, due to their 
unclear scope, interaction and adherence to the principles of the TBT Agreement, namely: the 
Practical Guidance of Cybersecurity Standards —Technical Specifications for  Certification of Cross -
border Handling of Personal Information; the Critical Information Infrastructure (CII) Security 
Protection Regulations; the Cybersecurity Review Measures; the Draft Regulations on Network Data 
Security; and the Draft Measures for Se curity Assessment of Cross -Border Data Transfer. In 
response, while failing to address Members' concerns, the Chinese delegation notes that the 
Cybersecurity Law "does not restrict foreign enterprises, technologies and products from entering 
the Chinese ma rket, nor does it restrict the lawful, orderly and free flow of data ". We respectfully 
disagree with this statement. Canada would like to urge China to recognize the concerns that have 
been raised by Members on these measures since 2017 and we reiterate ou r long -standing request 
for a notification of these measures, only one of which has been duly notified to date to this 
Committee.  
2.190.   The representative of Japan  provided the following statement. Japan continues to have 
concerns regarding China's Cybersecurity  Law and would like to refer to the previous statement we 
made at the last TBT Committee in July 2022. In this September, a draft amendment to the 
Cybersecurity Law was published. We would like to refer that we have submitted comments on the 
draft. In part icular, Article 65, which has been changed in the proposed amendment, stipulates 
penalties for critical information infrastructure operators who use network products or services that 
have not undergone "cybersecurity review" or have not passed "cybersecuri ty review". However, if 
the conformity assessment procedure is established based on China's own standards for this 
"cybersecurity review," depending on the contents of the conformity assessment procedure, it may 
cause unnecessary obstacles to the market en try of relevant foreign vendors and service providers, 
which may violate Article 5.1.2 of the TBT Agreement. We request that the content of the 
"cybersecurity review" be consistent with the TBT Agreement in its operation.  
2.191.   In addition, if the conformity ass essment procedures to be established do not comply with 
the technical content of the guidelines by the International Organization for Standardization, etc., 
and may have a significant impact on the trade of WTO member states, we request that it be notified  
in accordance with the provisions of Article 5.6 of the TBT Agreement. We are also aware that the 
Cross -border Data Transfer Security Assessment Measures, a subordinate regulation of the 
Cybersecurity Law, has been in effect since this September. The scop e of critical data that must be 
examined when exporting data out of the country and the definition of cross -border transfer are 
unclear, and industry has raised concerns about the possibility of excessive restrictions on cross -
border data flow. The period from the promulgation of this law to its enforcement was quite short 
(approximately two months), and it is difficult to say that foreign businesses have had sufficient 
time to prepare to comply with this law. From a business perspective, predictability is important, 
and we would like to request that the system be administered in a transparent manner so that this 
law does not become an obstacle to business.  
2.192.   The representative of the European Union  provided the following statement. The EU would 
like to refer to its statements at previous TBT Committees with regard to the Cybersecurity Law. The 
EU requests more clarity regarding several of the implementing measures of China's Cybersecurity 
Law. For example, the National Information Security Standardisation Tech nical Committee (also 
known as TC260) has released the draft of a short (non -binding) guideline on the identification of 
"important data" (the Identification Guideline). The concept of "important data" was first introduced 
by the Cybersecurity Law and has more recently been adopted into the Data Security Law. However, 
the term has still never been comprehensively defined. Under the Data Security Law, regional and 
sectoral regulators have already been tasked with formulating catalogues of "important data" fo r 
their respective sectors. The Identification Guideline, released on 13 January 2022, was the first 
step towards implementing this national classification system for "important data". The EU urges 
China to proceed with these guidelines as soon as possible  and take into account the EU comments 
submitted during the public consultation.  
2.193.   The EU has also taken note of the publication of the Outbound Data Transfer Security 
Assessment Measures by the Cyberspace Administration of China (CAC). Several issues have b een 
identified. Firstly, once the regulatory security assessment is triggered, the data handler may no 
longer be able to resort to signing a standard contract or to being certified for cross -border handling 
of personal information, transferring data across  borders, even when it comes to low -risk scenarios, G/TBT/M/88  
 
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  such as the intra -company transfers of employees' personal information by large MNCs. Secondly, 
for those that handle large amounts of personal information, even if only one piece of such 
information is t ransferred abroad, a regulatory security assessment will still be triggered, 
unnecessarily. Thirdly, it would be beneficial for the CAC to clarify that, as the Measures only concern 
the cross -border transfer of data, any thresholds they define are irreleva nt to local data storage 
obligations under the Personal Information Protection Law. Finally, the grace period for 
implementation is too short. Conversely, the EU seeks confirmation that under the Outbound Data 
Transfer Security Assessment Measures a locali zation requirement is not imposed. Additionally, we 
are concerned that they put foreign operators at a disadvantage compared to local ones. The scope 
of some of the provisions remains unclear and it is not possible to determine which types of data 
and whic h kinds of transfers would be covered by the measure. While these terms may be defined 
in other pieces of legislation, the concerns we have raised there would also apply here. For example, 
those subject to interpretation, in particular, the vague concepts of "important data " and "critical 
information infrastructure ". It would be important to address these issues to ensure legal certainty. 
The EU urges China to take on board its comments provided.  
2.194.   The EU has also taken note of the Critical Information Infras tructure Security Protection 
Regulation, which became effective as from September 2021. The Regulation provides long -awaited 
details about how critical information infrastructure operators will be designated and what their 
responsibilities will be, in orde r to protect the security of the networks that they build and operate. 
Since the Cybersecurity Law came into effect in 2017, EU companies have faced uncertainty about 
whether or not they and/or their customers would be deemed critical information infrastru cture 
operators and therefore face regulatory obligations in data security, procurement, cross -border data 
flows and other areas. However, the new Regulation does not resolve the overlap between the 
Ministry of Public Security (MPS) -administered system for  network security, known as the Multi -
Level Protection Scheme (MLPS, now MLPS 2.0) and the critical information infrastructure protection 
regime. The EU urges China to clearly distinguish between the compliance obligations – especially 
with regard to produ ct and service procurement – applicable to Critical Information Infrastructure 
on the one hand, and to networks above MLPS Level 3 on the other, as in reality, these two sets of 
obligations are becoming increasingly equal. The EU calls on China to implemen t the provisions in a 
non-discriminatory manner, respecting the principles of proportionality, necessity and technology 
neutrality, and ensure adequate protection of intellectual property (IP). The EU requests that China 
notify draft measures concerning an y sectoral implementation to the WTO.  
2.195.   The representative of the United States  provided the following statement. The United States 
remains very concerned about China's suite of cybersecurity and cryptography measures. As we 
have said in prior TBT Committee meetings, this is a major concern for US companies, given China's 
intertwined requirements for conformity assessment systems for security testing, technical 
regulations, and a multi -level classification scheme laying out requirements including mandatory 
standards and testing for the purchase of ICT goods across a wide range of commercial sectors. 
China's Cybersecurity Law entered into force on 1 June 2017, in spite of serious and long -standing 
concerns from the United States and many other international sta keholders. Since then, China has 
continued to develop, and in certain cases, finalize related implementing measures that are 
sometimes general in scope, and sometimes sector specific. Our numerous, long -standing concerns 
are clearly laid out in our past st atements to this Committee and remain unaddressed. Additionally, 
the United States reiterates its serious concerns regarding China's Cryptography Law, which went 
into effect on 1 January 2020. The United States is concerned that this law codifies potential ly far-
reaching, highly trade restrictive cryptography -related constraints on foreign ICT products.  
2.196.   Because these issues are technically complex and China's approach appears to be both novel 
and would have a potentially widespread impact in the commercial sector, the United States requests 
that China undertake in -depth consultations with the US Government, other WTO Members, and 
global stakeholders. We also request that China afford subsequent opportunities for interested 
parties to submit comments on revis ed iterations of draft standards and all other implementing 
measures related to the Cybersecurity Law. Given the broad potential impact of these standards and 
measures and the serious concerns they have raised, it is critical that China act deliberately to  
collaborate with all interested parties, and take their comments into account before adopting the 
drafts as written. We will continue to carefully monitor China's implementation of the Cybersecurity 
law and related measures, as well as the Cryptography La w. We look forward to continuing this 
important dialogue with you.  G/TBT/M/88  
 
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  2.197.   The representative of Australia  provided the following statement. Australia reiterates our 
previous position regarding China's Cyber Security Law and related laws, including the Personal 
Information Protection Law and Data Security Law. As we set out in Australia's submissions to 
China's consultation on the then proposed laws, we welcomed a number of revisions to both these 
draft laws. Nonetheless, Australia still has concerns around extra -territoriality, trade retaliation, 
compliance costs for firms and the overall scope. These concerns have still not been addressed in 
the latest draft changes to the law. We remain concerned about the lack of clarity when it comes to 
definitions, jurisdictio n and a number of other fundamental elements. We continue to urge China to 
take into account the concerns of business and Members in the implementation of these measures 
and development of future measures. We look forward to working closely with China on t hese issues.  
2.198.   In response, the representative of China  provided the following statement. Cyber Security 
Law came into effect on 1 June 2017. It is China's first basic, framework, and comprehensive law in 
the field of network security. The total of seven cha pters and 79 articles comprehensively and 
systematically establishes obligations and responsibilities in cybersecurity protection for relevant 
authorities, network operators, and network users. Basic systems have been established to ensure 
the security of network products and services, network operation, network data, network 
information, network security monitoring, early warning, and emergency response. The network 
security supervision and management system have been further clarified. The Cyber Security Law 
provides a legal basis for maintaining the security and development of cyberspace, and plays an 
important role in ensuring the security of cyberspace, purifying the cyberspace environment, and 
promoting the development of the cyber industry. Since the implementation of the law, the public's 
awareness of cyber security has been enhanced, the legal system of cyber security has been 
improved, the law enforcement capacity in cyberspace has been strengthened, and cyberspace has 
become cleaner and more orderl y. 
2.1.4.18   European Union - Transitional periods for MRLs and international consultations 
(ID 58047) 
2.199.   The representative of Costa Rica  provided the following statement. We reiterate our support 
for this trade concern. As it has done in previous meetings, Costa Rica  reiterates its request for an 
extension of the transition periods for compliance with the new tolerances established for 
agrochemicals, the approvals for use of which have not been renewed, in view of the impact they 
have on agricultural production in our  countries. The usual six -month period is insufficient when 
replacing an agrochemical being used, given the need to assess the possibility of longer transition 
periods for countries that produce and export fruit and vegetables.  
2.200.   The representative of Colomb ia provided the following statement. Colombia again raises its 
concern about the international consultation processes adopted by the European Union (EU) and the 
planned transition periods prior to the entry into force of provisions under which the EU no lo nger 
approves the marketing of certain plant protection substances and amends maximum residue limits 
(MRLs). These concerns are being reiterated because, to date, there has been no response to the 
requests for suitable transition periods, nor have the comm ents made during international 
consultation periods been taken into account. Regulatory changes on the use of plant protection 
substances, coupled with such short periods of transition, create difficulties and uncertainty for fruit 
and vegetable producing countries. They also create additional burdens for agricultural producers, 
who need to make decisions on the use of crop protection products a year or more before the goods 
arrive on the European market. This is particularly complex for products with long production and 
harvest cycles, as well as for processed and frozen foods, as, despite complying with European 
standards at the time of sowing, they may face regulatory changes that prevent exports at the time 
of harvest and distribution. Furthermore, Colom bia maintains that notification to the WTO regarding 
the non -renewal or the MRLs to be applied, as well as the transition periods, should not be made by 
the EU as a simple formality within the regulatory process.  
2.201.   As provided for in Articles 2.9.2 and 2.9.4 of the TBT Agreement, the notification must be 
submitted within a time frame that allows the Members concerned to submit substantive 
observations and comments for genuine consideration. In that connection, we wou ld like to know 
how the EU has taken into account the comments submitted by Members at different stages of the 
consultation process. Are there cases in which regulatory changes or adjustments have been 
effectively introduced using the information submitted  by stakeholders during the consultation 
 
47 For previous statements follow the thread under ID 580 . G/TBT/M/88  
 
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  process? How have comments been used to determine the transition periods for the implementation 
of standards? In addition to these questions, which we have raised previously, there are the 
questions that we have rai sed in other settings about the use of emergency authorizations, which 
benefit producers in the EU and in some non -EU countries, but which are not accessible on equal 
terms to all other countries. We invite the EU to follow the recommendations for good reg ulatory 
practices, under which standards must be based on clear and objective information, and which 
promote open dialogue with stakeholders, transparency and the minimizing of market distortions.  
2.202.   The representative of the United States  provided the follow ing statement. We continue to 
raise concerns regarding the European Union's (EU) practices related to the enforcement and 
reduction of pesticide maximum residue levels (MRLs). We recall longstanding concerns that the 
United States and our trading partners do not know with certainty what the impact of the EU's active 
substance non -approvals or restricted approval decisions will be on future MRLs. We have noted that 
EU MRLs and import tolerances are often reduced or withdrawn following a non -approval or restr icted 
approval decision. The United States continues to request that the EU complete, in its entirety, its 
science -based risk assessments prior to setting new MRLs. The United States also asks the EU to 
provide an opportunity in advance of the formal WTO n otification comment period for third -country 
data contributions. Such an approach will allow the EU to take all available evidence into account, 
prior to making an MRL decision. We have experienced instances where the review of additional data 
is only cons idered after the EU notifies its intention to not approve a renewal or to approve a renewal 
on a restricted basis. Further, we seek confirmation that the EU will allow for longer, more reasonable 
transition times for MRLs where the EU has not identified ri sks to consumers based on dietary 
exposure. We would have serious trade concerns if MRLs and import tolerances are lowered or 
withdrawn in a manner that is disproportionate to the level of risk to human health, and which, 
without clear scientific justifica tion, may be more trade restrictive than necessary.  
2.203.   The United States reiterates its request that the EU retains existing MRL levels while import 
tolerances are under consideration. A recent EU draft regulation now states that it will only consider 
import tolerance applications on a case -by-case basis dependent upon meeting its definition of 
"environmental criteria ". The EU's proposed new approach lacks clarity and predictability for farmers 
and growers. To prevent food waste and to enhance food security, w e request the EU extend the 
transition periods for MRLs where the EU has not identified risks to consumers based on dietary 
exposure. This will facilitate adequate time for the United States and third -country producers to 
move lawfully produced food produc ts through the channels of trade, including products with long 
shelf lives. The EU's policy of enforcing MRLs in effect at the time of importation for imported goods 
rather than at the time of production, as it applies for the EU's domestic goods, is incon sistent and 
causes disruptions in trade for products destined for the EU market. Trading partners have found 
themselves racing to move shipments through customs to prevent rejections or turning back orders 
because a product that previously complied with an  existing EU MRL at the time of production could 
potentially be rejected at EU borders. EU growers are not required to adhere to the same timelines 
under the current regulatory provisions, and the United States requests that MRLs for all products, 
both dom estic and imported, be enforced based on the date of production.  
2.204.   The representative of Ecuador  provided the following statement. My delegation once again 
reiterates its concern with regard to the procedures concerning the "transition al periods" adopted 
by the European Union for implementing its measures relating to the non -renewal of the approval  
of substances and the reduction of tolerances.  By Ecuador's understanding, in order to establish 
reasonable transition al periods, it is necessary to consider harve sting periods and the times when 
agrochemicals are applied. Farmers need more time to adapt to MRL requirements, as it takes at 
least 36 months to develop or register a new phytosanitary pest -control product, and that when new 
alternatives have been identi fied. It is estimated that around 20% to 40% of the world's crops are 
lost to pests each year. Of that loss, about one third is caused by fungal diseases. Crops such as 
bananas are particularly vulnerable to such pests, which include black sigatoka or, even worse , 
Fusarium R4T. With the policy of prohibiting substances such as imazalil, chlorothalonil, mancozeb 
and metiram, growers are left with no viable alternatives for countering these pests.  In view of the 
above, Ecuador urges the EU to consider the comments o f third countries before resolving to  reduce 
the minimum detection level of an active ingredient, particularly when the use of the substances is 
key for the control of pests or diseases typical of tropical and subtropical climates, conditions that 
differ f rom those of the members of the European economic bloc.  Lastly, we would like to reiterate 
our request to the EU for information on how the member State that has received an emergency 
authorization for the use of prohibited substances is complying with the  existing MRL regulations G/TBT/M/88  
 
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  and how the EU verifies, in the case of non -compliance with the MRL regulations, that the products 
containing the prohibited substances have not been marketed in other EU member States.  
2.205.   The representative of Brazil  provided the fo llowing statement. Brazil supports the concerns 
raised under STC 580 and would like to refer to our previous statements on this agenda item. We 
respectfully bring to the attention of the EU its obligations under Article 2.12 of the TBT Agreement, 
which rel ate to the establishment of a reasonable interval between the publication of technical 
regulations and their entry into force, except in cases of urgent problems of safety, health, 
environmental protection or national security. It is of utmost importance t hat the EU provides 
adequate transitional periods, especially for those cases in which the scientific opinions of the EFSA 
on the toxicity of substances are "inconclusive" or only indicate a "suspected risk". Transitional 
periods should also be compatible with the production processes, so as to allow producers – and 
especially small farmers – to adapt to the new regulations. In the last TBT Committee meeting, EU 
referred to its statement for the May 2020 meeting. By consulting the minutes of that meeting, t he 
Brazilian delegation found out that there the EU explains its views on what falls within TBT or SPS 
scope and provided some details of EU regulation procedures. We thank EU for these clarifications, 
but indeed, we would like the EU to explain how its au thorities deal with uncertainty, indicating if 
inconclusive evidence leads to suspension or prohibition of substances and which actions are taken 
to review these decisions, as they are based on inconclusive opinions.  
2.206.   The representative of Canada  provided t he following statement. Canada would like to 
reiterate its concern with the EU's approach to transition periods for maximum residue limits. Canada 
considers the sudden deletion of MRLs to be disproportionate to the level of risk to human health 
and more tr ade-restrictive than necessary. Canada is of the view that the EU's approach has yet to 
acknowledge the reality of agricultural supply chains such as the time required to ship product, 
multi-year inventory and extensive shelf life, including in foreign cou ntries. Sufficient transition 
periods will allow trade to continue uninterrupted, while providing adequate time for producers and 
exporters to adapt to the new EU requirements. At a time when ensuring food security is of high 
concern, Canada urges the EU t o extend transition periods for MRLs to third countries, as it has done 
so for its domestic producers, taking into account the need for exporters to adapt to new 
requirements.  
2.207.   The representative of Uruguay  provided the following statement. In view of harve sting 
periods, the stages at which plant protection products are applied, and the time required to develop 
and register alternative substances, in practice, the transitional periods granted by the European 
Union in the provisions amending the MRLs for acti ve substances are, in most cases, proving to be 
insufficient to make the necessary adjustments to production and ensure that agricultural products, 
especially processed or frozen products, comply with the new, lower MRLs. Six months is not enough 
time for this. In our view, any changes should be gradual, and a reasonable period of time should 
be granted to raise awareness in the productive sector and among technical advisers, and to make 
available on the market effective substitutes for the active ingredien ts for which the MRLs are to be 
reduced. It is inappropriate to make drastic changes to the rules in the middle of a harvest season, 
given the impact this may have on international and domestic marketing.  My delegation reiterates 
the call for Members to ad opt regulatory decisions based on internationally accepted standards or 
to present conclusive scientific evidence when it is strictly necessary to deviate from those standards 
to meet their legitimate aims, as provided for in the relevant WTO Agreements.  Even in cases where 
the European Union determines, on the basis of a full risk assessment, that it is necessary to reduce 
the MRLs of active substances used in agricultural production by other Members, we urge it to 
consider the need to grant adequate and s ufficient transition periods in order to make the relevant 
adjustments.  Lastly, we share the concerns raised by Colombia on the practical operation of the 
European Union’s international consultation process on this issue, and we reiterate the questions 
asked by that delegation on how the comments of other Members have been taken into account in 
the regulatory process, including on whether these comments have resulted in regulatory changes 
or adjustments.  
2.208.   The representative of Kenya  provided the following st atement. Kenya raises its concern 
regarding the European Union 's process of the transition period granted prior to the entry into force 
of (default) Maximum Residue Limits (MRLs) after the withdrawal of authorization of use of plant 
protection substances. The changes in the non -authorization of use have affected third countries 
and in particular Kenya 's production system. The non -authorization of some plant protection 
substances has made it difficult for Kenyan producers, who are mainly small holder famers to change 
production practices in the middle of the production cycles, especially given the short period given G/TBT/M/88  
 
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  for the entry into force of default MRLs.  Kenya wishes to support the other delegations who have 
raised this issue and urges the EU to provide lo nger transition periods on the entry into force of 
default MRLs before to avoid disruption of trade due to non -compliances of products destined to the 
EU market. Kenya would also request clarity on the matter with regards to rationale on transition 
periods  of MRLs and urges the EU to follow recommendations on good regulatory practices.  
2.209.   The representative of Panama  provided the following statement. We endorse the statements 
made by the delegations that have already taken the floor. As in previous meetings, P anama would 
like to express its concern about transitional periods for compliance with the new tolerances being 
established. We urge the European Union to extend the transitional period to enable small exporting 
producers to adapt to the regulations impose d as the current timeframe is insufficient.  
2.210.   The representative of Guatemala  provided the following statement. Following the lowering 
of maximum residue levels (MRLs) notified by the European Union, Guatemala wishes to reiterate 
the need for transitional pe riods consistent with the stages of crop production and the time needed 
for efficiency tests to be carried out for the evaluation of alternative substances and for them to be 
effective, in particular for crops grown in tropical countries. The productive se ctors require more 
time to adapt and, in particular, to find alternative substances, which in some cases means having 
to wait for suitable production cycles to commence application and testing. This can take up to 
three  years depending on the crop. Some se ctors are currently testing new active substances and 
organic methods. For example, the banana sector started testing a substitute substance in 
January  2022. However, the results on its effectiveness will only be available at the end of 2023 
and, depending  on those results, the time required for its full assessment in production will have to 
be extended. This test has resulted in a 20% loss of production in the testing area this year, due to 
the ineffectiveness of alternative substances. However, the test n eeds to be completed to determine 
its actual effectiveness. This is to provide a real -world example of evidence of why we have said that 
six months is not enough time — although it is not a short time either — for productive sectors to 
prepare. Real timesc ales are required to allow productive sectors to adapt according to their 
production chain and seasonality.  
2.211.   The European Union must consider not only the climatic conditions of its trading partners, 
but also the challenges that these regulatory changes imp ose on producers and rural communities 
in tropical countries, as they put at risk people's incomes and food conditions, not to mention the 
added costs of transitioning to an effective alternative substance, assuming one exists. We would 
be highly grateful if the European Union would consider the following: launching a genuine dialogue 
to discuss the importance of establishing transitional periods that closely follow the stages of crop 
production, following the lowering of MRLs for active substances that are  commonly used for the 
phytosanitary treatment of these crops; extending the transitional period, with a view to not raising 
barriers to trade, and giving developing countries with tropical climates time to adapt; and providing 
an explanation as to how the  comments of the Organization's Members are taken into account in the 
process and decisions on European regulations.  
2.212.   The representative of Paraguay  provided the following statement. As with other similar 
concerns and as stated in previous meetings of this and other committees, we are concerned that 
the European Union's approach to limiting the use of substances is more trade -restrictive than it 
needs to be for it to achieve its legitimate objectives under the TBT  Agreement.  The pursuit of such 
policies will  cause significant trade damage to the economies of developing countries and jeopardize 
their ability to achieve the Sustainable Development Goals, including those related to food security.  
We urge the EU to reassess its approach and, where MRL reductions are duly justified, provide 
adequate transitional periods that take into account the realities of the production processes and 
geographical locations, including distances, of its trading partners.  With regard to international 
consultations, we thank the EU for the notification of measures of this type; however, we echo the 
questions raised by Colombia regarding how the EU has considered comments submitted by 
Members at different stages of the consultation process and whether there are cases where 
regulato ry changes or adjustments have indeed been introduced based on information submitted by 
those concerned in the process since, as we have said with regard to other trade concerns, the 
limited time between the end of the comment period and the approval of th e drafts without 
modifications leads us to believe that these notifications and comment periods are mere formalities 
and comments are not intended to be taken into account , and in fact are not taken into account.  
2.213.   The representative of Argentina  provided th e following statement. We once again reiterate 
our concern about the EU policy of removing import tolerances for substances that are no longer G/TBT/M/88  
 
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  used in the EU, which is clearly a more restrictive measure than necessary and goes beyond the 
acceptable level o f risk set by the EU. The approach taken by the EU to establish transitional periods 
for MRLs is hasty and does not take into account the needs and adaptive capacities of third countries. 
The transition period clearly needs to be longer, and Argentina ther efore calls for a review of the 
transition periods.  
2.214.   In response, the representative of the European Union  provided the following statement. 
The European Union thanks the WTO Members for raising this issue. The EU has provided detailed 
information on transi tional periods for Maximum Residue Levels (MRLs) at previous TBT Committees, 
in particular, at the TBT Committee meeting in May 2020 and July 2021. The EU considers that 
measures lowering maximum residue levels due to concerns for human health, fall under the remit 
of the SPS Committee and should be discussed in that context. On the contrary, all measures 
concerning the non -approval or restriction of active substances used in plant protection products in 
the EU and a limited number of very specific measures  lowering MRLs, due to environmental issues 
of global concern (e.g. clothianidin and thiamethoxam), are notified to the TBT Committee. These 
measures do not have direct consequences on SPS -related matters. In the interest of transparency 
and, further to re quests by some Members, when notifying these measures under the WTO/TBT 
notification system, the EU additionally informs the SPS Committee of the submission of these 
notifications. In practice, both Committees are informed about draft acts on the non -appro val or 
restriction of approval of an active substance in the EU. However, comments should only be 
submitted via the TBT notification system in these cases. The EU would like to point out in this 
context that the commenting deadlines are always respected an d that the comments received within 
those deadlines are duly taken into account in the EU's decision -making process.  
2.215.   In the interest of efficient proceedings in both Committees and, in line with the respective 
Agreements, the EU would invite Members to rai se matters on approvals of active substances and 
measures dealing with MRLs in view of environmental issues of global concern exclusively in the TBT 
Committee, while matters relating to MRLs for pesticides due to human health concerns should be 
raised excl usively in the SPS Committee. Issues concerning transitional periods for MRLs should 
therefore generally be raised at the Committee to which the original notification was made, which 
would be, in most cases, the SPS Committee.  
2.1.4.19   European Union - Chlorothalon il (pesticide active substance), G/TBT/N/EU/625  
(ID 57948) 
2.216.   The representative of Costa Rica  provided the following statement. Once again, Costa Rica 
supports Colombia's comments and we refer to previous statements expressing concern about the 
measure notified by the European Union in  document G/TBT/N/EU/625 , in relation to the non -
renewal of the approval of the active substance chlorothalonil. Costa Rica thanks the EU for its 
willingness to hold a dialogue on agrochemicals policy, taking into consideration international 
obligations on foreign trade and the agric ultural and environmental policy objectives of the member 
countries of the international community, together with the commitment to leave no one behind in 
the implementation of its Green Deal policy.  
2.217.   The representative of Colombia  provided the following st atement. Colombia again raises its 
concern regarding the measure notified by the European Union (EU) in document G/TBT/N/EU/625  
relating to the non -renewal of the approval of the active substance chlorothalonil. Despite the 
technical and scientific comments submitted within the consu ltation period, the regulation blocking 
renewal of the market approval for this substance entered into force. Furthermore, Commission 
Regulation (EU) 2019/677 of February 2021, which set the MRL or the limit of detection, entered 
into force in September 20 21. In this case, the EU has also failed to take into consideration the 
technical comments submitted and the requests for a longer transition period to adapt production 
processes, which, as we know, are particularly complex in the agricultural sector. Not only are these 
measures being taken in a manner that is inconsistent with international standards, such as those 
of the Codex, but they are also being applied inequitably, as, in practice, their implementation and 
authorization for use differentiate betwee n domestic and foreign producers. This is so in the case of 
"emergency authorizations", which allow EU producers to continue to or resume use of this 
substance. While Colombia recognizes the health and environmental protection objectives, these 
measures ha ve been adopted without any proof that they are indeed the least trade -restrictive 
means of ensuring an appropriate level of protection, which constitutes a violation of Article 2.2 of 
 
48 For previous statements follow the thread under ID 579 . G/TBT/M/88  
 
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  the TBT Agreement. The measures adopted must be based on scientific evi dence and international 
standards and take account of the biodiverse agriculture of tropical countries such as Colombia. To 
conclude, we note that producers and exporters have questions and concerns regarding the 
inspection and control mechanisms and proce dures for demonstrating compliance with the 
requirements, about which we do not have sufficient clarity for foreign trade operations to be 
predictable.  
2.218.   The representative of Ecuador  provided the following statement. Ecuador reiterates its 
concern in relati on to notification  G/TBT/N/E U/625  on the non -renewal of the approval  of the active 
substance chlorothalonil.  Chlorothalonil is mainly used for controlling black sigatoka in bananas, as 
a fast -acting fungicide with a multi -site mode of action, meaning that the risk of fungal resistanc e is 
low. Controlling black sigatoka ( Mycosphaerella fijiensis ) is the main challenge for banana production 
in Latin America. To control the disease, strategies of rotating fungicides with different modes of 
action are pursued to avoid fungal resistance to  these compounds.  The climate in Ecuador is tropical, 
so pests and their behaviour are different from those in the European Union. Certain active 
substances and their formulations are indispensable in agricultural production to prevent crop losses 
and resu lting harmful economic and social effects.  Therefore, Ecuador urges the European Union to 
consider the particular circumstances of tropical countries when implementing the measures adopted 
and to take a more balanced approach in line with the Codex Aliment arius. Ecuador understands 
that for an MRL to be established, banned or lowered there must be conclusive scientific information 
demonstrating a real health impact.  Reducing the MRL for chlorothalonil could have a very significant 
economic impact on small -, medium -, and large -scale producers in Ecuador. This is because the 
banana sector provides jobs for 2.5 million people. Exports of this product account for a significant 
share of the country's foreign exchange earnings (2.1 billion). This equates to 2% of GDP and 35% 
to agricultural GDP.  Lastly , we wish to reiterate that no substitute or similar plant protection  products 
with the same environmental or toxicological profile are currently available, since the alternatives to 
chlorothalonil (mancozeb, metiram) are also under review by the EU.  
2.219.   The representative of Brazil  provided the following statement. Brazil supp orts STC 579 and 
refers to its previous statements on the matter. We believe that the EU's decision to base measures 
on a hazard -based approach, without an adequate risk analysis and with no compliance with long -
standing scientific principles is inconsiste nt with WTO rules. The non -renewal of approval for 
chlorothalonil by the EU did not duly consider that it is currently authorized in more than 100 
countries, and that the MRLs allowed by Codex could reach up to 70 mg/kg. We stress our systemic 
concern with  the fact that some hazard -based analyses conducted by the European Food Safety 
Agency (EFSA) led to the non -renewal of approvals of some substances and subsequently to the 
reduction of their MRLs. The Brazilian National Health Agency has set MRLs for chlo rothalonil applied 
to more than 30 crops. The case of chlorothalonil is particularly harmful towards Brazil`s producers 
of banana, coffee, citrus fruits, papaya, watermelon, among others.  
2.220.   The representative of Paraguay  provided the following statement. This concern and the 
non-renewal of the approval of chlorothalonil and other substances were already discussed 
extensively both in this Committee and in the SPS Committee because of the subsequent reduction 
in the MRLs. Paraguay therefore refers to its previo us statements and requests that its statement at 
the previous meeting be reflected in full in the minutes of this meeting.  We once again request that 
the European Union take into consideration information on pesticides provided by the specialized 
agencies recognized by the WTO, such as the Codex Alimentarius, reconsider its approach and base 
its decisions on conclusive scientific evidence and real risk weightings, in accordance with 
international standards and principles, and ensure import tolerances.  
2.221.   State ment from June 2022 meeting, in full.49 This concern and the non -renewal of the 
approval of chlorothalonil and other substances was already discussed extensively both in this 
Committee and in the SPS Committee because of the subsequent reduction of MRLs. P araguay 
therefore refers to its previous statements and requests that its statement at the previous meeting 
be reflected in full in the minutes of this meeting. We once again request that the European Union 
take into consideration information on pesticides  provided by the specialized agencies recognized by 
the WTO, such as the Codex Alimentarius, reconsider its approach and base its decisions on 
conclusive scientific evidence and real risk weightings, in accordance with international standards 
and principle s, and ensure import tolerances.  
 
49 G/TBT /M/87 , para. 2.332.  G/TBT/M/88  
 
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  2.222.   The representative of Guatemala  provided the following statement. Guatemala maintains its 
position on this trade concern regarding the use of chlorothalonil because there is currently no 
information on scientific evidence o f the possible harm to human health caused by consuming fruits 
and vegetables, particularly those produced in Latin America, and because no molecule on the 
market is currently as effective for controlling the Ascochyta fungus, above all in vegetables.  
Alternative substances to chlorothalonil include mancozeb, azoxystrobin, pyraclostrobin, sulphur and 
difenoconazole. The registration of four of these alternative substances was not renewed for 
marketing in the European Union, and, as a result, MRLs have been  reduced to almost zero tolerance, 
leaving Guatemalan agricultural production with no options that can effectively combat diseases of 
fungal origin. In view of this situation, Guatemala reiterates its request to the European Union to 
consider the similar c ircumstances of tropical countries when implementing measures, until it has 
conclusive studies and has aligned itself with the provisions of the Codex Alimentarius. Guatemala 
therefore requests that the risk assessment approach and scientific evidence be c onsidered and that 
MRLs be set that correspond to the reality of tropical countries. Tropical countries cannot be required 
to use the same treatments as European countries, since their climatic conditions are different For 
this reason, we ask that the MRLs  for chlorothalonil be reviewed, taking into account that no chemical 
substance on the market can replace this compound.  
2.223.   In response, the representative of the European Union  provided the following statement. 
The EU thanks WTO Members for raising this issu e once more. As explained at previous meetings, 
the EU proposed not to renew the approval of chlorothalonil through Commission Implementing 
Regulation (EU) No 2019/67750, adopted on 29 April 2019 and previously notified to the TBT 
Committee. Following the non-renewal of approval decision, the EU prepared a draft Regulation 
lowering the Maximum Residue Limits (MRLs) for chlorothalonil, which was notified to the WTO/SPS 
Committee ( G/SPS/N/EU/394 ). In view of the concerns identified by the European Food Safety 
Authority (EFSA), the EU lo wered all MRLs for chlorothalonil to the relevant limits of quantification 
through Commission Regulation (EU) 2021/15551 of the 9 February 2021. The new values are 
applicable to all food products since the 2 of September 2021. Since then, there has been no further 
developments in the EU on this substance, as no new data were received. Import tolerance requests, 
which need t o be supported by substantial new data addressing the concerns, remain possible and 
will be assessed on a case -by-case basis by the "rapporteur " member State and the EFSA.  
2.1.4.20   Peru - Supreme Decree No. 015 -2019 -SA, which amends the Manual of 
Advertising Warni ngs approved by Supreme Decree No. 012 -2018 -SA (ID 61852) 
2.224.   The representative of Brazil  provided the following statement. Brazil regrets having to once 
again express its concerns regarding labelling requirements expressed in the Manual of Advertising 
Warnin gs approved by Supreme Decree 012 -2018-SA (notified under G/TBT/N/PER/7/Add.1)  and 
amended by Supreme Decree 015 -2019-SA (unnotified). The use of stickers is a widespread practice 
internationally, as it does not affect the provision of reliable information to consumers. C odex 
standard CODEX -STAN 1 -1985 for pre -packaged goods, Articles 8.1.1 and 8.2.1, explicitly allows for 
the possibility of using additional labels or stickers, as long as they are attached to the packaging 
and if the language of the original label is not n ecessarily that of the consumer for whom it is 
intended. Brazil shares Peru's endeavour to ensure the highest health standards through technical 
regulations that help to better inform consumers. Despite Peruvian legitimate concerns with 
deceptive practices , advances in labelling technologies allow for their safe affixation. We 
acknowledge that, according to Supreme Decree 005 -2022-SA, the entry into force of the prohibition 
on stickers was delayed until 31 December 2022. However, Brazil would like to respec tfully ask Peru 
to permanently align its labelling requirements with current international standards established 
under the Codex and withdraw the prohibition of stickers for the products under the scope of the 
Manual of Advertising Warnings. Brazil conside rs such postponement a provisional solution and will 
 
50 Commission Implementing Regulation (EU) 2019/677 of 29 April 2019 concerning the non -renewal of 
the approval of the active substance chlorothalonil, in accordance with Regulation (EC) No 1107/2009 of the 
European Parliament and of the  Council concerning the placing of plant protection products on the market and 
amending Commission Implementing Regulation (EU) No 540/2011. OJ L 114, 30.04.2019, p. 15.  
51 Commission Regulation (EU) 2021/155 of 9 February 2021 amending Annexes II, III and V to 
Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue 
levels for carbon tetrachloride, chlorothalonil, chlorpropham, dimethoate, ethoprophos, fenamidone, 
methiocarb, omethoate, propiconazole and pymetrozi ne in or on certain products. OJ L 46, 10.2.2021, p. 5.  
52 For previous statements follow the thread under ID 618 . G/TBT/M/88  
 
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  continue to raise this STC until Peru permanently removes its burdensome requirements for food 
labelling.  
2.225.   The representative of Colombia  provided the following statement. Colombia would again like 
to rai se this trade concern regarding the use of adhesive advertising warning labels as outlined in 
the Manual of Advertising Warnings of Supreme Decree No.  012-2018-SA. In fact, in accordance 
with Decree No. 005 -2022, as of 1 January 2023, labels cannot be used  and warnings must be 
printed directly onto the product's packaging. On previous occasions,  it has been suggested that the 
use of adhesive labels does not distort the purpose of the standard, since the warnings, whether 
included on adhesive labels or print ed directly on the packaging, will continue to be clear, legible, 
prominent and comprehensible. In fact, with current technology, self -adhesive labels can be printed 
which do not peel off the packaging, thus guaranteeing that they will remain affixed, desp ite not 
being printed directly onto the packaging. It is therefore in our interest, and surely that of other 
countries as well, to use adhesive labels indefinitely. Furthermore, we believe that the policy under 
which this regulation is adopted, even though  it is designed to protect public health, should be 
implemented in a manner that does not create an unnecessary obstacle to trade. For Colombia, 
initial trade association estimates indicate that this measure particularly affects small and medium -
sized busi nesses, which have exported approximately USD 53 million worth of processed foods to 
Peru. It has also created logistical distribution -related issues, as establishments generally require 
compliance with standards in advance so that at the time of sale to e nd consumers compliance is 
guaranteed. At the same time, this measure is affecting product competitiveness, as it increases 
costs, because producers must install different packaging lines or contract third parties to package 
products separately depending o n the country of export. Lastly, we welcome the bilateral talks that 
have taken place at different levels and invite the parties to continue working in a coordinated 
manner and to take the above -mentioned considerations into account, allowing the use of ad hesive 
labels indefinitely.  
2.226.   The representative of the European Union  provided the following statement.  The European 
Union (EU) appreciates that Peru further extended the possibility for imported products to use 
stickers for compliance with labelling requi rements for processed foods, until 31 December 2022. 
However, the EU would like to repeat once again the urgent invitation to Peru to provide for a 
permanent possibility for imported products to use stickers. The repeated and unforeseeable 
extensions of th e deadline severely disrupt trade because retailers in the Peruvian market stop 
buying products with stickers several months before each deadline. Such disruptions represent 
significant losses for importers and producers, as well as disruption of trade flo ws and unavailability 
of the affected products in the Peruvian market. The EU recognizes that reliable information to the 
Peruvian consumer and protection of public health are legitimate objectives. Nevertheless, the 
obligation to print information on the product package is unnecessarily trade -restrictive and 
represents a disproportionate burden for foreign producers, in particular SMEs. In the EU and in 
most countries around the world, stickers are allowed for food products, provided that the 
information i s accurate and the stickers are not easily removable. We invite once again Peru to 
bilaterally work with the EU on this issue.  
2.227.   The representative of Costa Rica  provided the following statement. Costa Rica wishes to 
maintain its trade concern regarding the process to implement the draft regulation established under 
Supreme Decree No.  015-2019-SA, which amends the Manual of Advertising Warnings approved by 
Supreme Decree No.  012-2018-SA of Peru. Costa Rica would like to thank Peru for extending the 
deadline f or using adhesive labels. However, this temporary solution does not provide our exporters 
with legal certainty and clarity about the regulations applicable to trade in food in Peru. Progress 
needs to be made on an amendment to the final regulation, which w ould allow the use of self -
adhesive labels for an unlimited period. It should be noted that the use of adhesive labels is widely 
recognized internationally, as such labels achieve the same public health protection and consumer 
information purposes achieved  by permanent labels. At the CODEX level, for example, Articles 8.1.1 
and 8.2.1 of CODEX -STAN  1-1985, General Standard for the Labelling of Prepackaged Foods, permit 
the use of supplementary and adhesive labels, as long as it is guaranteed that they will n ot become 
separated from the container, or in cases where the language on the original label is not acceptable 
to the consumer for whom it is intended. Costa Rica respectfully requests that the Peruvian 
authorities consider permitting the use of adhesive l abels on a reciprocal basis, given that these 
labels may be used on Peruvian food products to be marketed in Central America. We request the 
Peruvian authorities to provide information on the status of this regulation, whether the intention is 
still to ban  the use of stickers on labels and the timing of the regulation's entry into force.  G/TBT/M/88  
 
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  2.228.   The representative of Chile provided the following statement. The delegation of Chile would 
like to thank the delegations of Brazil, Colombia and the European Union for inc luding this specific 
trade concern on the agenda. Our delegation urges the regulatory authority of Peru to allow the 
permanent use of adhesives on the packaging of food products and thereby avoid creating an 
unnecessary technical barrier to trade. Finally,  we would like to thank Peru for the bilateral 
discussions that we have had on this topic.  
2.229.   The representative of Paraguay  provided the following statement. As stated at previous 
meetings, Paraguay supports Peru's objective of protecting public health and considers that the 
provision of information to consumers through labelling is an appropriate strategy. However, we 
share and support the concerns expressed by other Members with regard to the time limit 
established for the use of supplementary labels.  It should be noted that the use of labels of this kind 
is widely recognized internationally, as such labels achieve the same public health protection and 
consumer information purposes achieved by permanent labels. Not accepting them is therefore more 
trade -restrictive than necessary.  As regards the grace period granted to allow the use of such labels 
until 31  December  2022, not only will it expire soon, but the temporary extensions do not provide 
legal certainty for exporters.  Therefore, we ask Peru to allo w the use of this type of adhesive labels 
indefinitely and to bear in mind the provisions of Article 2.2 of the TBT Agreement.  
2.230.   The representative of Guatemala  provided the following statement. We reiterate the 
recognition of Peru's right to protect people' s health and to provide the consumer with information 
on foods. Supreme Decree No. 005 -2022-SA published on 31 March 2022 in the Official Gazette, El 
Peruano , extended the deadline to 31 December 2022 for the use on imported products of stickers 
displaying  advertising warnings as provided for in the Manual of Advertising Warnings approved by 
Supreme Decree No. 012 -2018-SA, in the framework of the provisions of Law No.  30021 on the 
Promotion of Healthy Eating for Children and Adolescents, and its Regulations  approved by Supreme 
Decree No.  017-2017-SA. Peru is again requested to reconsider the use of a supplementary label, 
as its use is widely recognized at the international level, as specified at previous Codex Alimentarius 
meetings and in Codex CXS 1 -1985, b ecause it allows the same objective of public health protection 
and consumer information to be achieved. There is an international standard, which will ensure that 
trade is not hindered more than necessary, and so we call on Peru to apply this measure beca use 
the sticker fulfils the same function and achieves the legitimate objective pursued by Peru.  For the 
record, Guatemala reiterates its statements made at previous meetings of the Committee. We would 
be grateful if Peru could keep this Committee informe d of developments and changes in this 
regulation.  
2.231.   In response, the representative of Peru provided the following statement. In this regard, 
Peru reiterates that it is committed to its work to protect the health of its citizens and vulnerable 
groups, such a s children and adolescents, through public policies aimed at achieving this goal, in 
accordance with the country's international trade commitments in this area. In this connection, Peru 
is seeking to ensure that the information contained in the Manual of A dvertising Warnings (MAP) 
reaches consumers clearly and effectively to enable them to make informed choices.  In response 
to the concerns expressed by some Members, Peru, in accordance with what it indicated at the 
previous meeting of the TBT Committee, th rough Supreme Decree No.  005-2022-SA, extended until 
31 December 2022, the period during which the use of adhesive warning labels is allowed, as 
provided for in paragraph 8.3 of section 8 of Supreme Decree No.  012-2018-SA approving the MAP 
under Law No. 30 021 on the promotion of healthy eating among children and adolescents.  In this 
regard, as has already been mentioned on previous occasions, we are coordinating with the Ministry 
of Health of Peru in order to be able to have a definitive response on this i ssue. We also reiterate 
that Peru wishes to honour its WTO commitments and therefore reaffirms its commitment to not 
preparing, adopting or applying technical regulations that may create unnecessary barriers to trade.  
2.1.4.21   India - Order related to requirement o f Non -GM cum GM free certificate 
accompanied with imported food consignment, G/TBT/N/IND/168  (ID 65153) 
2.232.   The representative of the United States  provided the following statement. This is the fifth 
TBT Committee in a row that the United States must raise its concerns with India's mea sure 
mandating "non-GM (genetically modified) origin and GM free certificates " for certain agricultural 
imports into India, notified on 2 September 2020, as G/TBT/N/IND/168 , and a later notified entry -
into-force date of 1 March 2021. To date India has not responded to our questions  regarding its 
 
53 For previous statements follow the thread under ID 651 . G/TBT/M/88  
 
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  rationale for requiring a non -GM certificate on a consignment basis. India has previously referenced 
its Environment Protection Act (1986), Rules 1989, and the absence of Genetic Engineering Approval 
Committee (GEAC) approvals for the 24 cro ps listed in the Order as evidence that the non -GM 
requirement is neither new nor trade restrictive. The United States must stress that while India's 
authority to regulate "GM" foods is neither new nor in question, the requirement of a non -GM 
certificate f rom a competent authority on a consignment basis was first ordered in 2020 and caused 
trade disruptions to US apple and rice shipments in 2021. The absence of approvals from GEAC 
highlights the lack of transparency and inefficiency in the approval process,  compounding the burden 
India is placing on its trading partners. The United States has previously proposed technical 
cooperation and dialogue with the Government of India on numerous occasions. We once again 
request that India engage with the United State s and trading partners to find a less trade -restrictive 
alternative.  
2.233.   The representative of the European Union  provided the following statement. The European 
Union would like to refer to its previous statements on this matter. The EU submitted comments to 
the TBT notification asking for further clarification which have not been replied to and the Order 
already entered into force. The EU considers that the India requirements go beyond what is 
necessary to achieve the stated objective and put an additional bur den and costs on EU exporters. 
The EU would invite India to explain why it considers necessary to impose such a burden on trading 
partners with a high prevalence of non -GM food on their domestic market and a robust regulatory 
regime governing the use of GM s. In addition to the fact that only a limited number of the food crops 
referred to in the Annexure are authorized to contain GMs, there are very strict traceability and 
labelling requirements applicable to food that contains GMOs. The EU would like to ask  India to waive 
the requirement to attach the certificate for food items.  
2.234.   The representative of Japan  provided the following statement. Japan reiterates that the 
measure which requires 24 agricultural products imported by India to be accompanied by a 
certificate stating that they are not of genetically modified origin and do not contain genetic 
modification, is not based on scientific principles or proper risk assessment, and is more trade -
restrictive than necessary and could have negative impact on agricul tural trade between India and 
other WTO Members. In Japan, under domestic laws, the import, distribution, cultivation, and other 
general uses of genetically modified agricultural products for human consumption are subject to 
safety evaluations, and agricul tural products that are not approved by the evaluation process could 
not be imported nor distributed domestically. If certain items are already under appropriate control 
in the origin country, there is no scientific rationale to require non -GM origin and/o r GM free 
certificates for those items. Japan requests India to withdraw the requirement to the attachment of 
certificates for foods that are properly controlled in the origin country.  
2.235.   The representative of Australia  provided the following statement. Austr alia thanks India for 
its ongoing engagement and cooperation regarding the use of the "non-GM origin and GM free 
certificate ", as well as India's previous responses provided in the TBT Committee. Australia shares 
the view that GM use in agriculture needs t o be safe, and we are strong supporters of robust, risk 
and science -based regulation of GM. Australia reiterates that it is common international practice to 
maintain regulatory oversight and controls on agricultural crops subject to genetic modification. 
Requiring GM assurances on a consignment -by-consignment basis does not improve regulatory 
outcomes. In order to ensure that trade is not subject to unnecessary costs and additional regulatory 
burdens for both Australian exporters and Indian importers, Austr alia requests that India implements 
alternative arrangements, which recognize the existing regulatory systems in place by countries to 
control GM exports. Australia maintains appropriate regulation of GM -crops and is able to provide 
assurances of which cro ps are and are not subject to GM. Australia will work with India to seek a 
mutually agreeable solution that facilitates free and open trade, in accordance with the principles of 
the recently signed Australia -India Economic Cooperation and Trade Agreement ( AI-ECTA). Australia 
looks forward to further collaborative engagement with India on this matter.  
2.236.   The representative of Canada  provided the following statement. Canada would like to 
reiterate concerns raised at previous TBT Committee meetings, SPS Committee  meetings, and the 
Council for Trade in Goods regarding the implementation of India's August 2020 Order, which 
mandates that a non -genetically modified (or GM free) certificate accompany imported consignments 
of 24 imported food products. As detailed in Ca nada's comments submitted through India's TBT 
Enquiry Point in October 2020, we are concerned that India's Order will disproportionately impact 
the ability of GM -producing countries to export to India and unnecessarily restrict international trade. 
Canada welcomed India's decision to accept Canada's attestation for non -GM certification on bean G/TBT/M/88  
 
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  exports. However, Canada continues to encourage India to consider a less burdensome approach to 
meeting the Order's stated food safety goals.  
2.237.   The broad scientific con sensus is that food products derived from biotechnology that have 
undergone a rigorous scientific safety assessment according to internationally accepted guidance 
and standards are considered as safe as their conventional counterparts. Until a satisfactory  solution 
is found and to minimize potential trade disruptions, Canada again requests that India suspend the 
implementation of this measure and that trade be permitted to continue without a certificate 
requirement. This would allow for further engagement w ith Members to discuss and consider an 
alternate, less trade -restrictive measure to meet India's intended objective. Finally, given the 
Order's stated objective "to ensure the safety and wholesomeness of articles of food imported into 
India", Canada reiter ates its request that India notify the non -GM Order to the SPS Committee. We 
remain available and would welcome the opportunity to pursue further discussions on this issue in 
a bilateral setting.  
2.238.   The representative of Uruguay  provided the following stateme nt. Uruguay recognizes India's 
right to take measures to guarantee food safety and the health of its population.  However, Uruguay 
would like to recall the existing international consensus that genetically modified products, approved 
by exporting countries on the basis of Codex recommendations in relation to the risk assessment 
methodology, are equivalent to their conventional counterparts.  Therefore, and with due regard for 
the responses already provided by India, in our view, there would not appear to be a ny technical 
justification for the implementation of the proposed certification measure proposed by India, taking 
into account the legitimate objective, as stated in the relevant Indian standard, of ensuring the 
safety and wholesomeness of imported foods. In view of this objective, we would like to ask why 
the delegation of India continues to fail to notify the WTO SPS Committee of the reference measure, 
despite having notified the TBT Committee, as requested by Uruguay and various other Members.  
Uruguay would like to reiterate how important it is for Members to establish measures based on 
scientific principles, and, in particular, for these measures to be implemented with the objective of 
minimizing negative trade effects, in line with the provisions of t he TBT and SPS Agreements.  We 
remain attentive to any comments and replies of the delegation of India in relation to the concerns 
of Members, as have been expressed for almost two years by numerous delegations, including 
Uruguay, in both Geneva and New Del hi. 
2.239.   The representative of Paraguay  provided the following statement. Paraguay reiterates its 
concern that this measure may create an unjustified assumption that GM  food products evaluated 
and authorized on the basis of sound regulatory processes are less s afe than non -GM food products. 
GM products have undergone rigorous scientific safety assessments in accordance with international 
standards, guidelines and recommendations to ensure that they are considered as safe as their 
conventional counterparts. We lo ok forward to India's replies to the questions posed in both Geneva 
and New Delhi, and join others in requesting that this measure also be notified to the SPS Committee 
given that its objective, according to India, is health and food safety.  
2.240.   The representa tive of Argentina  provided the following statement. With regard to this 
measure, Argentina reiterates its concern and again stresses that the measure has no scientific 
explanation to support it. In this connection, we echo the statements made before us. Ar gentina is 
concerned that this requirement would set a precedent and could be a barrier to trade, which in the 
future could extend to other products or even their derivatives. We therefore request India to 
consider reviewing this measure.  
2.241.   In response, the representative of India provided the following statement. We would like to 
make the following points: The Environment Protection Act (1986) and its Rules prescribe that no 
person shall import or export genetically engineered organisms/substances or cells e xcept with the 
Genetic Engineering Approval Committee (GEAC). DGFT Notification No.2 (RE -2006)/2004 -2009 
dated 7  April 2006 on "Import of Genetically Modified Food" stated that import of GMOs/LMOs for 
food will be governed by the provisions of the Environm ent Protection Act, 1986 and Rules 1989. 
The GEAC has so far not approved any of the crop varieties of genetically modified/engineered origin 
listed on the Order mentioned above. As of date, exporters from several trade partners like the US, 
UK, Australia,  Canada, Turkey, Iran, China, EU including Italy, Germany, and France and Thailand, 
are already providing requisite certificates. Hence, in our assessment, this order is not trade -
restrictive. On similar lines, India also issues such certificates for its o wn exports to other countries. 
The Government of India has authorized the Export Inspection Council (EIC) as the nodal agency 
for issuing Non -GMO certificates for export consignments. The EIC has issued more than 9,000 non -G/TBT/M/88  
 
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  GMO certificates for the export o f primary food crops as well as processed food products for export 
to several countries. With this background, we would request the interested delegations to share 
specific issues being faced with respect to this order.  
2.1.4.22   India – Draft Food Safety and Standa rds (Import) Amendment Regulation, 2020, 
G/TBT/N/IND/180  (ID 66754) 
2.242.   The representative of Mexico  provided the following statement. The delegation of Mexico 
refers to its statement at the previous meeting of this Committee in July  2022, where it raised a 
concern for the second time regarding the draft Food Safety and Standards (Import) Amendment 
Regulation, notified by the Government of India to the Members of this Committee on 25 November 
2020 in document G/TBT/N/IND/180 . In this regard, the Mexican delegation reiterates its concern 
about the proportionality  and scope of the measure, specifically with regard to alcoholic beverages. 
At the July 2022 meeting of the Committee, the delegation of India indicated that the detailed 
guidelines with information on procedures and guidance were still under consideration  and that the 
Food Safety and Standards Authority of India was in the process of developing guidelines, in relation 
to which sufficient time would be provided for compliance. We would therefore be grateful if any 
updated information in this regard could be  shared with us, in order to be able to follow it up in a 
timely manner, considering its great importance for Mexico’s industry and Government.  
2.243.   The representative of the United States  provided the following statement. The United States 
remains concerned wi th India's draft measure, notified to the WTO TBT Committee as 
G/TBT/N/IND/180 . As the United States has stated in the past five TBT Committee meetings, this 
draft regulation leaves many unanswered questions for foreign food manufacturing facilities, 
competent authorities, and othe r stakeholders. The draft regulation states that India may identify 
categories of "risk" for food products "from time to time … for which inspection or audit of foreign 
food manufacturing facilities producing such categories of foods shall be mandatory. " We are 
concerned about the lack of detail regarding the scope of this proposed technical regulation and the 
scientific and technical information India will use to determine the specific "risk" for food product 
categories. During the July 2022 Committee meet ing, India noted that "procedural information and 
guidance " was being developed for this measure. Will such procedures and guidance be notified, and 
does India have a timeline for notification of this information?  
2.244.   The representative of the European Union  provided the following statement. The European 
Union would like to refer to its previous statements on this matter. At the outset, the European 
Union recalls that it awaits a written reply to the comments it had sen t in February 2021 to the 
notification G/TBT/N/IND/180 . We again respectfully ask India to reply in writing to the EU 
comments, given the importance of providing exporting countries with clarity and certainty about 
India's import requirements. Referring to the FSSAI Order of 10 Oct ober 2022, we would like to 
thank India for clarifying, even if only in general terms, the scope of products/food categories subject 
to the registration of foreign food facilities, and for postponing the entering into force of the new 
requirements to 1 Feb ruary 2023.  
2.245.   However, given the: disruption to trade associated to the new registration of facilities, even 
if they are not associated to new sanitary measures; generic nature of the list of products/food 
categories; absence of any criteria to define the ri sks associated to the mentioned list; number of 
unanswered questions by India; and finally, importance of the competent authorities and companies 
in the exporting countries to have sufficient time to adapt, the EU would like to ask India to: Further 
postpo ne the date of entering into force for, at least, 12 months; Clarify the meaning of "entering 
into force ", i.e. whether it corresponds to the "date of arrival in India" or the "date of departure from 
the exporting countries"; Provide a list of HS product c odes with, at least, 4 digits, and the risks 
associated to each of the products/food categories; Define the term "facilities "; Make easily 
accessible, at all times, the import sanitary measures of India which are applicable to each of the 
products/food cat egories subject to the registration of facilities; Clarify where and to whom the lists 
of facilities already registered will be made available by India; Clarify the modalities related to 
inspections (and audits) of the facilities by India and by the compet ent authorities of the exporting 
countries; Provide written guidance to the exporting countries and companies on how they should 
register the facilities and send the lists of facilities to India, and to maintain it updated; Consider 
avoiding that the compe tent authorities of the export countries have to sign more than one certificate 
with the same sanitary measures; and, finally, to notify, well in advance, its measures related to the 
 
54 For previous statements follow the thread under ID 667 . G/TBT/M/88  
 
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  registration of establishments also to the WTO SPS Committee. The EU woul d like to thank India for 
its willingness to meet to discuss all these matters.  
2.246.   The representative of New Zealand  provided the following statement. New Zealand would 
like to thank India for verbal information shared to date on this draft requirement and th e recent 
order that clarifies the products for which manufacturer registration is required. However, New 
Zealand believes the registration and auditing of foreign manufacturing premises creates 
unnecessary trade restrictions and that this should be managed  by the exporting country's 
competent authority rather than the importing country. Notwithstanding these concerns, New 
Zealand remains interested in seeing detailed written guidance on this proposed requirement 
including the implementation process as well as criteria for audits, before it is brought into force. 
New Zealand also has concerns with the level of proposed detail required for registration which 
currently includes product names and HS codes, rather than just product type.  
2.247.   The representative of Australia provided the following statement. Australia recognizes the 
right of the Indian Government to take measures necessary to protect public health. Australia thanks 
India for clarifying that this regulation only applies to five food categories. This is i n line with FSSAI's 
previous advice that the proposed regulations would not apply to all food establishments. Australia 
would appreciate information on India's risk assessment which concluded that additional measures 
were required for the registration of f ood manufacturing facilities with FSSAI. Australia can further 
advise that it has specific legislated export control measures for those categories of food mentioned 
in India's revised regulation. Australia would appreciate the opportunity to streamline the  process 
so as to reduce the level of administrative burden for all our industries. We suggest India consider 
the food safety systems of its trading partners in applying the regulation. Australia is happy to work 
with India to support a more risk -based app roach to food safety.  
2.248.   The representative of Canada  provided the following statement. Canada would like to 
reiterate concerns raised at the TBT Committee since February 2021 regarding India's draft 
amendment to its Food Safety Standards (Import) Amendment R egulation pertaining to the 
registration, inspection and/or audit of foreign food manufacturing facilities producing food products 
destined for India. While Canada recognizes India's right to take necessary measures to protect 
public health and safety, a n umber of elements contained in India's proposed amendments remain 
ambiguous. As previously stated, it is unclear what criteria would be used to determine the level of 
risk for food products imported into India and what circumstances would instigate an audi t or an 
inspection of a foreign manufacturing facility. In addition, Canada remains concerned with the 
measures on target commodities, implementation plan, audit rates, compliance actions and appeals. 
We are of the view that India's approach in these areas  could create unnecessary obstacles to trade. 
Canada notes that India has yet to respond to comments submitted to India's Enquiry Point on 21 
January 2021. We would appreciate if India could inform when it expects to provide the requested 
details. In closi ng, Canada recalls its request to India to notify these amendments to the SPS 
Committee given that India's proposed regulation covers food safety measures aimed at protecting 
human health and safety.  
2.249.   The representative of Argentina  provided the following statement. We reiterate the concerns 
raised at the last meeting of this Committee. As we have already stated, Argentina has a number of 
doubts about giving effect to and implementing the provisions of the regulation, particularly in  
relation to the products covered and the provisions on registering, inspecting and auditing exporting 
establishments. All our questions have been duly submitted through India's TBT Focal Point. They 
have also been sent in a timely manner to a range of rel evant competent authorities. We have yet 
to receive the corresponding clarifications. We hope to receive them as soon as possible and also 
hope that these new standard does not become an unjustified restriction, in order to ensure that 
trade with India, a highly important trading partner for Argentina’s agricultural sector, is not 
affected.  
2.250.   In response, the representative of India provided the following statement. Food Safety and 
Standards Authority of India is a statutory body for laying down science -based  standards for articles 
of food and to regulate their manufacture, storage, distribution, sale and import, to ensure 
availability of safe and wholesome food for human consumption and for matters connected 
therewith. In pursuance to the section 25 of the Fo od Safety and Standards Act, 2006, FSSAI 
regulates and ensures the safety of food being imported in the country. Accordingly, to envisage 
robust food safety and monitoring system, FSSAI has notified Draft Food Safety and Standards 
(Import) Amendment Regula tions, 2021 dated 3 November 2021 which provides the legal framework G/TBT/M/88  
 
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  for registration and inspection of foreign food manufacturing facilities. Further, as per the 
regulations, the registration and inspection of such facilities will be based on risk of food  categories 
as specified by the Food Authority from time to time. The Draft regulations were also notified at 
WTO portal for inviting comments. The comments have been received from various member 
countries with respect to procedures and the list of commodi ties for which manufactures need to 
give details for registration.  
2.251.   To address all such issues, FSSAI vide order dated 10 October 2022 notified that the 
registration of foreign food manufacturing facilities falling under Milk and Milk Products, Meat and 
Meat Products including poultry, fish, and their products, Egg powder, Nutraceuticals, Foods for 
Infant Nutrition and manufacturer desirous to export such article of food to India shall register with 
the Food Authority before exporting to India. For this purp ose, the Competent Authorities of the 
exporting countries are requested to provide the list of existing manufacturers and of those intended 
to export such food products to India. Further, some countries have already started providing the 
list of manufactur ers intend to export these products to India. Since, as of now India requested the 
competent authorities of the exporting countries to provide list of manufacturers intent to export 
India, there is no requirement of any SOP/Guidelines as of now for registr ation of foreign food 
manufacturers for the current mechanism as it is open and transparent. The practice of 
Listing/Registration of Foreign Establishment is already prevailing in various countries like EU, Korea, 
Canada, USA and similar procedures are bei ng in place. India being a developing country and one 
of the biggest food market in world, ensuring safety and quality of food is utmost needed and under 
the mandate of Food Safety and Standards Act. This provision will ensure the safety and quality of 
foods being manufactured for import into India and also help to reduce time taken for the inspection 
and clearance at ports.  
2.1.4.23   Egypt – Halal Certification Measure, based on Egyptian Standard ES 4249/2014 
General Requirements for Halal Food According to Islamic Sharia, G/TBT/N/EGY/313 , 
G/TBT/N/EGY/313 /Add.1 , G/TBT/ N/EGY/313/Add.2  (ID 71855) 
2.252.   The representative of Canada  provided the following statement.  Canada joins the United 
States, the European Union and other intervening Members to raise its continued concerns with 
Egypt's new halal certification requirements fo r all imported food and beverage products. Canada 
understands Egypt's objective to ensure that Egyptian consumers are confident that they are buying 
and consuming Halal -certified products in agreement with Islamic Sharia. However, we also believe 
that such  measures should not create unnecessary barriers to international trade or be more trade -
restrictive than necessary to fulfil that objective. While Canada appreciates Egypt notifying this 
measure to the WTO TBT Committee in December 2021, it failed to do s o prior to the implementation 
date of 1 October 2021. Members have an obligation to provide trading partners with adequate time 
to comment on a given measure (at least 60 days) and have those comments taken into 
consideration prior to that measure being fi nalized. As per WTO obligations, a six -month period 
between the notification of the final measure and its entry into force is considered a reasonable 
amount of time to provide industry time to adapt to the new requirements. While Canada appreciates 
the add itional clarification provided in the notification of this measure to the WTO TBT Committee in 
August of 2022, Canada is seeking further clarification on the timeline for the implementation of this 
measure.  
2.253.   Although Canada appreciates Egypt's delayed imple mentation of the Halal certification for 
dairy products, Canada still remains concerned with the lack of details, documentation and specificity 
on how these requirements will be implemented and how specific products will be impacted. Canada 
encourages Egyp t to reconsider this measure considering the degree of uncertainty, lack of clear 
implementation protocol, and unnecessary added cost and administrative burden. For example, the 
proposed new regime only specifies one Egyptian certification body that will h ave the authority to 
certify halal products for the Egyptian market. It is our understanding that this has already 
significantly raised the halal certification fee which will have to be borne by exporters of halal 
products to Egypt. The new measure could r esult in a certification process that is overly burdensome, 
costly and more trade restrictive than necessary to achieve Egypt's stated objective. Canada strongly 
encourages Egypt to have open and transparent discussions with trading partners to share 
information, further clarify the requirements under this new measure and consider the impact it may 
 
55 For previous statements f ollow the thread under ID 718 . G/TBT/M/88  
 
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  have on trade. Until then, we respectfully request that Egypt suspend the implementation of the 
measure.  
2.254.   The representative of Kenya  provided the following state ment. Kenya 's concern on this 
regulation is that the Egyptian authorities insist that only their firms can carry out Halal certification.  
Kenya has a Halal Certification Body that Egypt can partner with to meet their halal objective. This 
measure is deemed  to be more trade restrictive than necessary when Egypt requires that it  is only 
ISEG Halal Egypt that can certify exports from other countries.  It is also contrary to the principle of 
national treatment by restricting who can carry out Halal certification . This is contrary to Articles 2.2 
and 2.1 of the TBT Agreement , respectively.  This measure will be too expensive for Kenya 's exports 
to the Egyptian market hence making Kenyan products uncompetitive. Kenya requests that Egypt 
should work with the Kenyan H alal certification bodies  
2.255.   The representative of the European Union  provided the following statement. The European 
Union would like to express concerns with regard to the requirements on Halal certification as of 1 
October 2021 based on the Egyptian Halal s tandard 4249/2014. The EU industry is worried about 
the negative impact of this measure on food and beverages imports to Egypt. The EU regrets that 
Egypt notified to the TBT Committee the requirements for the importation of meat, poultry and their 
products , milk and dairy products only on 1 December 2021, after their entry into force for milk and 
dairy products on 1 October 2021, and that the notification did not include the text of the measure. 
The EU appreciates that the requirement for dairy products was  then suspended until 1 October 
2022; further suspension of the requirement would be welcome until the issues regarding 
certification process and costs are fully clarified as explained below. The EU recalls that, according 
to Article 2.9.4 of the WTO TBT A greement, Members shall allow a reasonable time (at least 60 days) 
for other Members for written comments on their draft measures, so that comments can be taken 
into account. In any case, the EU submitted written comments on 26 January 2022 and would 
welco me a reply by the Egyptian authorities. In this context we would like to appreciate the Egypt's 
notification from August, addendum to the notification 313 ( G/TBT/N/EGY/313/Add.3) , providing 
more HS codes of covered products, information on relevant procedures and on l abelling 
requirements.  
2.256.   Nevertheless, a number of important and practical information for economic operators is still 
missing, such as deadlines for issuance of certificates by IS EG Halal, details on audits, etc. Finally, 
EU comment regarding the monopolis tic position of the IS EG Halal, does not seem to have been 
taken into account either. The EU would like to thank Egypt for useful bilateral contacts. We 
welcomed the facilitating measures notified to the TBT Committee on 4 April 2022, which extended, 
until 30 September 2022, the period in which imports of milk and dairy products were accepted in 
Egypt without a Halal certificate. However, some of those facilitation measures were only temporary 
and affected companies need more time to adapt to the new certi fication and labelling requirements. 
Therefore, the EU would urge Egypt to postpone the implementation of this measure and to provide 
for a reasonable adaptation period of at least one year between the publication of the measures -
updated rules on Halal ce rtification and labelling requirements - and their entry into force, in 
accordance with Article 2.12 of the TBT Agreement.  
2.257.   The EU would like to invite Egypt to reconsider the decision to grant the right to certify the 
compliance with Halal requirements to a single company, IS EG Halal, and to provide for a Halal 
certification system that would allow multiple, well -established certification entities, in accordance 
with the international best practices. Re -certification by IS EG Halal of products from establi shments 
already certified by other companies is an unnecessary duplication and would lead to longer time to 
market and higher costs for consumers, while Egypt is suffering food security problems. The EU 
would welcome clarification on whether multiple Halal  certification entities, including from third 
countries, would continue to be allowed for imports, as it is understood from point 6 of the original 
TBT notification form. The EU would like to ask Egypt to consider keeping the Halal certification and 
labell ing voluntary for dairy products, in order to pursue the legitimate objective of ensuring reliable 
information without unduly hindering trade flows. Consumers should be able to decide whether to 
buy Halal -certified food or not, based on clear labelling. Th e EU would appreciate if Egypt would 
consider further trade facilitating measures, such as requiring Halal certification for the product and 
not per container, as well as proportional costs of Halal certification that take into account the 
international pr actice and correspond to the service rendered.  
2.258.   The EU understands that the new requirements on Halal certification will certify the 
compliance with Egyptian standard ES 4249/2014 on General requirements for "Halal" food products G/TBT/M/88  
 
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  in accordance with the prov isions of Islamic Sharia. According to the available information in the 
TBT notification form G/TBT/N/EGY/313/Add.3 , this standard is updated and will be notified to the 
WTO TBT Committee. The EU provided comments on the draft updated Halal standards via the EU 
delegati on in Cairo and would appreciate they are taken into consideration. Finally, the EU would 
like to ask Egypt about the concrete steps envisaged to provide comprehensive information about 
the new measures and clear written and publicly available guidance to stakeholders, including a 
detailed description of the certification procedure, its duration, costs, and required documents, as 
well as the process for registration of suppliers. The EU would also like to know whether Halal 
certificates will be required for  products that are not 100% milk, but which contain milk or milk 
ingredients amongst others. The EU is ready to work with Egypt on solutions that would prevent the 
negative impact this measure would have on food and beverages imports to Egypt.  
2.259.   The represen tative of the United States  provided the following statement. The United States 
recognizes Egypt's right to assure its consumers of certain products' compliance with the precepts 
of Islamic Law through a halal certification. The United States appreciates E gypt verbal commitment 
to delaying implementation of its new halal requirements for three months (1 January 2023) 
following US requests; the United States also requests that Egypt notify this change in an addendum 
notification to the TBT Committee so that Egypt's trading partners are aware of this change. This 
present delay in implementation, and the delays preceding it, have not resolved the United States' 
underlying concerns. We understand that Egypt's halal standard, ES 4249, is intended to serve as 
the basis for its halal requirements; however, the current standard does not provide adequate 
information for producers to understand, nor comply with, this measure. To date, Egypt has not 
notified the implementing procedures necessary for compliance. This unc ertainty has negatively 
impacted agricultural trade, which is particularly concerning during a period of global food insecurity. 
Specifically, we respectfully request that Egypt consolidate all implementing procedures into a draft 
technical regulation and notify this measure to the WTO. These should include a clear product scope, 
specific halal criteria that producers must meet, conformity assessment procedures, fee structures, 
audit procedures (if audits are to be required), and other details necessary for  overseas producers 
and certifiers to meet these new import requirements.  
2.260.   In regard to product scope, we note that the product scope Egypt has outlined in its latest 
notification that would be covered under the halal certification would seem to also includ e "crude 
milk;" a product that has been explicitly exempted from halal certification requirements in the same 
notification. We request that Egypt clarify the product scope and define "crude milk ", along with 
harmonized system (HS) codes associated with the  product that would be excluded. Until these 
procedures have been notified, the United States requests that Egypt suspend enforcement of any 
new halal requirements and requests a reasonable implementation period of at least six months 
after finalization of  this measure to allow producers to adapt their production methods to meet 
Egypt's new halal requirements. The United States further requests that Egypt notify the criteria it 
will use to approve overseas halal certifiers. In Egypt's latest notification, G/TBT/N/EGY/313 /Add.3 , 
it noted that there is only one certifier approved to provide halal certification services. Since 2019, 
when halal certification was granted to one company, certification fees for US beef products to Egypt 
have increased by approximately 1,000%. Gi ven increasing food prices and global supply chain 
disruptions, the United States requests that Egypt allow certifiers, which meet its criteria, to provide 
halal certification under this measure. The United States looks forward to Egypt's response and 
toward continuing to work with Egypt to ensure that its consumers have access to affordable and 
nutritious halal food products.  
2.261.   The representative of New Zealand  provided the following statement. New Zealand would 
like to thank Egypt for ongoing dialogue on th eir proposed Halal standard and the recent further 
extension for the inclusion of dairy. New Zealand continues to respect Egypt's desire to ensure 
Egyptian consumers can be assured of the Halal status of their imported food, but remains concerned 
with aspe cts of the proposed Halal requirements including having only one approved Halal 
certification body. In addition, the inclusion of all dairy products requiring halal certification does not 
follow globally accepted norms for food products. New Zealand unders tands, by their nature, dairy 
products are intrinsically Halal and should not require Halal certification (other than dairy products 
with added non -dairy animal product ingredients). New Zealand asks for Egypt to please clarify this 
and issue a final regul ation with Halal registration requirements that includes a sufficient notification 
period to implement any new requirements once the new standard is finalized and formally notified. 
Will the additional registration requirements as noted as free text in G/TBT/N/EGY/313/A dd.3 be 
part of legislated requirements, or a guidance document? We note our understanding that any 
registration requirements for manufacturers or exporters will not be required before the final Halal G/TBT/M/88  
 
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  standard enters into force. New Zealand encourages Egyp t to apply the least trade restrictive 
requirements in relation to Halal and welcomes further engagement with Egypt on this matter.  
2.262.   The representative of Australia  provided the following statement. Australia recognizes 
Egypt's right to implement religious requirements to ensure that Egyptian consumers can identify 
and purchase products which meet their needs. Australia also thanks Egypt for ongoing bilateral 
communication and engagement on the implementation of new Halal certification requirements. We 
welco me Egypt's third addendum to G/TBT/N/EGY/313  on 15 August 2022 which clarifies products 
that require Halal certification as an Egyptian import requirement. We also welcome the additional 
information related to the procedures exporting slaughterhouses and factories must undertake to  
export to Egypt. However, Australia respectfully requests that information of this nature, including 
further procedural information, be provided as part of a draft technical measure for notification to 
the WTO, as opposed to an addendum document. Australi a notes that it provided written comments 
to G/TBT/N/EGY/313  in January 2 022 and would welcome a response from Egypt. Australia invites 
Egypt to separately notify the TBT Committee of the revised Egyptian Standard 4249 "General 
Requirements on Halal Food according to Islamic Sharia" as advised in addendum three before 
finalizat ion and publication. Australia welcomes ongoing discussion on the implementation of Egypt's 
new Halal certification measures to ensure they meet Egypt's policy goals while also ensuring 
measures are not more trade restrictive than necessary.  
2.263.   The representa tive of Switzerland  provided the following statement. Switzerland continues 
to follow this matter with interest. We support the concerns raised by other Members with regard to 
the requirements on halal certification based on the Egyptian Halal standard 424 9/2014. While 
Switzerland recognizes Egypt's legitimate objective of providing consumers with reliable information 
on the halal integrity of certain products, we are concerned over the potential negative impact of 
these measures on bilateral trade. We beli eve that such measures should not be more trade 
restrictive than necessary to ensure legitimate objectives are met. In this respect, we call on Egypt 
to provide flexibility for the continued recognition of foreign Halal certification bodies and to clarify 
the details and criteria for the acceptance of foreign Halal certificates. In our understanding, the 
current proposal grants the right to certify the compliance with Halal requirements only to one single 
company. As in the previous meetings of the WTO TBT Committee, Switzerland invites Egypt to 
comply with the notification obligations under the TBT Agreement and provide detailed information 
about the implementation of the new measure.  
2.264.   The representative of Argentina  provided the following statement. Argenti na reiterates its 
concern about this measure and the lack of detailed and complete information on it. The 
postponements of the entry into force of the new regime are not a solution and do not allay concerns 
and worries about it. These concerns relate mainl y to the lack of transparency and predictability, as 
there is no information on the certification procedures or other regulatory details. In this regard, we 
again request Egypt to provide the necessary information and that the measure not be implemented 
until this detailed information is available.  
2.265.   The representative of Paraguay  provided the following statement. We regret to have to 
continue to support this concern but, despite repeated submissions, we still do not have the 
requested information.  Paraguay s hares Egypt's interest in providing its consumers with certainty 
regarding the purchase and consumption of halal -certified products, but the lack of clear information 
and details on application procedures prevents operators from being able to adapt to comp ly with 
them.  Paraguay again requests Egypt to suspend the implementation of new halal certification 
requirements until members have all the requested information and business operators have 
sufficient time to adapt in order to comply.  
2.266.   In response, the rep resentative of Egypt  provided the following statement. Egypt would like 
to thank Canada, Kenya, the European Union, the United States of America, New Zealand, Australia, 
Switzerland, Argentin a and Paraguay for their comments and continued engagement on the  Halal 
certification requirements for the imports of the products specified in G/TBT/N/EGY/313  and its 
addenda . Since its first notification in December 2021, Egypt has been keen to respond to the 
comments and concerns of Member countries and its trading partners through numerous f ormats 
including bilateral exchanges, the Egyptian TBT Enquiry Point or through notifying further Addenda 
to the original notification in order to address the issues of common concern.  I would also like to 
note that it has been almost a year since the orig inal notification was made and in the interim Egypt 
has delayed the entry into force of the requirement of imports of milk and dairy products to be 
accompanied by the halal certificate. Noting that to date no imports of milk and dairy products have G/TBT/M/88  
 
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  been de nied entry into Egypt if not accompanied by a halal certificate. The substance of the 
requirement and the implementing procedures through which it is implemented as set by the General 
Organization for Veterinary Services (GOVS) have not changed since the i nitial notification.  Hence, 
the delay introduced by Egypt has provided the economic operators with the appropriate period of 
time to adapt to the requirement.  It is also noteworthy that Egypt 's import data of dairy products 
indicate that the flow of trade has not been disrupted as a result of the requirement. In fact , 
comparing the volume of Egypt 's imports of dairy products from the world during the first seven  
months of 2021 and 2022, there has been a minor decrease that cannot be attributed to the halal 
certification requirement. The impact of the multiple crises faced by our countries on prices and 
hence on demand should be taken into account.  
2.267.   In its latest addendum G/TBT/N/EGY/313/Add.3 , Egypt was keen to clarify the points raised 
by Members during the previous TBT Committee meetings and bilaterally:  the scope of the products 
has been defined in HS code as requested by all countries. In this respect, I have to stress that the 
scope is limited and confined to the specified products as notified. The original notificatio n and its 
addenda never contained a reference to requiring a halal certificate for imports of all agricultural 
products. Since the original notification it was meat and poultry and their products and milk and 
dairy products (except for crude milk).  The lat est addendum also clarified the procedures involved 
in Halal certification as applied by the currently approved certification body by GOVS.  It also clarified 
the labelling requirements that are issued by the currently approved and recognized certification 
body by GOVS.  Furthermore, responding to Members ' questions on the status of the revision of 
ES 4249 "General requirements on Halal food according to Islamic Sharya", the latest addendum 
noted that the final draft has been finalized and avail able for comments from Egypt 's TBT Enquiry 
Point. Indeed , a number of countries have provided their comments during the 60 days comment 
period and have been replied to.  
2.268.   ES4249 comprises 9 Articles and two tables that cover: the scope; definitions and 
termi nology; the general requirements for Halal Food; instruments, vessels and production inputs; 
storage, display and transport; cleanliness, health and safety conditions; Inspection and approval; 
display in the markets; and Halal Labelling. The two tables inc luded in the standard provide for: ( i) 
Categorization of what is not Halal; ( ii) The food products that shall have a Halal Certificate according 
to product label and its ingredients.  It is also important to clarify that the Egyptian standard (ES) 
4249 does  not and shall not provide for any supervision requirements for a specific certification 
body. The relevant authority is the one to recognize the certification body that certifies compliance 
with halal requirements that is currently ISEG Halal. In case of approval of other certification entities , 
it will be duly notified.  Finally, Egypt would like to express its appreciation and readiness to continue 
engagement with all members on this topic.  
2.1.4.24   Indonesia - Government Regulation 28 of 2021 – Implementing Regu lation (for 
the Manufacturing/Industry Sector) to Law No. 11 of 2020 the "Job Creation Act" (ID 
72456) 
2.269.   The representative of the United States  provided the following statement. The United States 
continues to have serious concerns with the Government of Indonesia Regulation No. 28 of 2021, 
which is the Implementing Regulation (for the Manufacturing/Industry Sector) to Law No. 11 of 2020 
of the "Job Creation Act " (GR28/2021). We refer Indonesia to our previous three statements - from 
November 2021, and March and July 2022. Many of our concerns remain unanswered. Without 
reiterating them, we ask Indonesia to respond, and we again strongly request In donesia to ensure 
that all domestic conformity assessment bodies are continuing certification of foreign products. What 
is the status of the Ministry of Industry implementing regulations? Will Indonesia fulfill its 
transparency obligations by notifying the se regulations in draft form to this Committee prior to 
finalization? What is the justification for requiring conformity assessment testing to be conducted by 
Indonesian citizens residing in Indonesia? How do these requirements relate to the ability to per form 
conformity assessment? Why is Indonesia not allowing remote factory inspections, given travel 
restrictions and disruptions that may prevent onsite inspections? Does Article 38 require that 
conformity assessment bodies must also operate their own testi ng laboratories for all products 
required to be certified to SNIs? We again urge Indonesia to immediately communicate to Indonesian 
conformity assessment bodies that certification of foreign product shipments can, and should, 
continue while MOI prepares th e implementing regulations.  
 
56 For previous statements follow the thread under ID 72 4. G/TBT/M/88  
 
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  2.270.   The representative of the European Union  provided the following statement. The European 
Union is seriously concerned by Government Regulation No.28 of 2021 and new requirements for 
Indonesian National Standard (SNI) certificatio n. This Regulation is one of the implementing 
regulations of the Omnibus Law on Job Creation (Law 11/2020). Government Regulation 28/2021 
aims to increase the competitiveness of Indonesia's national industry and mainly outlines measure 
related to raw mater ials. It also introduces new requirements with regard to product certification 
bodies (Lspros). The new requirements affect in principle all products subject to SNI certification 
and it is very complex and burdensome to export to Indonesia. In addition, du e to lack of guidelines, 
the situation has not progressed and industry continue to report serious difficulties. Certain sectors 
appear to be particularly concerned, this is the case of toys, tyre and machinery industry. The 
European Union refers for the re cords to its previous statements, respectively in November 2021, 
March 2022 and July 2022 and notes that the majority of the issues remain unanswered. The 
European Union invites Indonesia to respond to our concerns and in particular to make sure that the 
conformity assessment bodies will continue certificating foreign products without unnecessary delays 
and complex procedures. The European Union also invites Indonesia to notify to the WTO the 
Government Regulation 28/2021 before going ahead with its impleme ntation; and to provide 
adequate time for consultation with the industry considering the sweeping changes at issue. We 
remain available to discuss the issue also bilaterally.  
2.271.   The representative of Canada  provided the following statement. Canada joins the U nited 
States and the European Union to raise its concerns with this measure, referring to our statement 
at the previous TBT Committee in paragraphs 2.402 -2.404 of G/TBT/M/87 . Some Canadian industry 
stakeholders have reported that the situation remains the same and the various requirements of  
this measure continue to represent unnecessary barriers to trade with Indonesia. Canada kindly asks 
that Indonesia provide the Committee with a response that specifically addresses concerns raised 
today by the US, EU and Canada.  
2.272.   In response, the represent ative of Indonesia  provided the following statement. Indonesia 
would like to refer to its last statement at the TBT Meeting in July 2022, and in our bilateral 
discussions. Indonesia will response all the concerns through formal written letter sent to the E nquiry 
Point of the concerned Members. With regard to the provisions for conformity assessment bodies to 
conduct SNI certification as regulated in this regulation, Indonesia is of the view that such provisions 
are a general requirement. The certification p rocess for technical regulations based on SNI in the 
industrial sector is carried out in accordance with the provisions contained in the related Ministerial 
Regulation. All provisions regarding standard and conformity assessment scheme apply equally for 
both domestic and foreign manufacturers. Indonesia will notify the TBT Committee on the technical 
regulations regarding the mandatory implementation of SNI for each industrial product and will take 
into consideration all the comments. Indonesia accepts testi ng results from accredited foreign testing 
laboratories under the mutual recognition arrangement framework and the availability of technical 
regulatory agreements between Indonesia and its partner countries.  
2.1.4.25   South Africa - Regulations Relating to the Label ling of Alcoholic Beverages - 
revision, G/TBT/N/ZAF/48/Rev.2/Add.1  (ID 75457) 
2.273.   The representative of Mexico  provided the following statement. The delegation of Mexico 
refers to its statement made at the previous meeting of this Committee in July 2022 on the 
Regulations relating to the composition, production and labelling of wine and spirits intended for sale 
in the Republic of South Africa, notified to the Members of the Committee on 20  December 2021 in 
document G/TBT/N/ZAF/48/Rev.2/Add.1 . In this regard, Mexico ki ndly requests the Government of 
South Africa to consider the requests to grant tequila and mezcal their own class and to recognize 
the specifications for their production, as set out in the applicable Mexican standards for each. This, 
in order to different iate them from the "100% Agave" class included in the South African Regulation 
in order to avoid misleading practices, which may mislead or confuse consumers. The South African 
Government is also requested to provide the relevant justification for the reje ction of export 
certificates for tequila and mezcal that demonstrate compliance with the applicable Mexican 
regulations for both beverages, as well as for using the name "100% Agave" in its Regulation for a 
class that excludes beverages from Mexico, taking  into consideration that these words undoubtedly 
evoke Mexican beverages and are linked to the designation of origin of tequila. We also request 
South Africa to comply with WTO transparency obligations and to allow a reasonable interval 
between the publica tion of technical standards and their entry into force (i.e., six months). Lastly, 
 
57 For previous statements follow the thread under ID 754 . G/TBT/M/88  
 
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  we appeal to the good offices of the South African delegation to consider Mexico's request to hold a 
bilateral meeting with the South African authorities as soon as possible  and to allow the participation 
of tequila regulatory authorities in Mexico, in order to follow up on this Regulation, as well as on the 
concerns raised in this statement  
2.274.   The representative of the European Union  provided the following statement. The EU tha nks 
South Africa for notifying their proposed revisions to their alcohol beverage composition, production, 
and labelling regulations in December 2021. The EU sent written comments on 16 February 2022. 
The EU – through a letter sent on 21 October 2022 by th e Ambassador to South Africa - also on 
behalf of several EU member States' Ambassadors to South Africa - to the Director General of the 
Department of Agriculture, Land Reform and Rural Development – also requested clarifications and 
raised concerns with sp ecific aspects of these regulations. This was furthermore supported by a 
letter of the Italian Ambassador to South Africa's Minister Didiza sent on 25 October 2022. Our key 
concerns relate to the following South African categories: spirit aperitif, gin, de scription of pot still 
brandy and vintage brandy. The amended regulation related to the composition, production and 
labelling of wine and spirits intended for sale in the Republic of South Africa was published on 15  July 
2022. These new regulations will en ter into force in December 2025 for products already approved 
on the South African market, but seem to apply already for products not yet approved prior to 
15 July 2022. South Africa has already started to block products not yet approved by South African 
Authorities which do not meet the criteria set in the new rules. This does not apply to products that 
had received an approval from South Africa prior to publication of the new rules in the Gazette, as 
we understand, as the new rules will only apply to them  in December 2025, but is still concerning 
and impacts a number of EU products.  
2.275.   While some of our concerns concerning the new spirit aperitif category have been taken on 
board (including safeguards on how the name of the spirit used for production of this drink can be 
used and displayed on the label and comments in relation to gin), there are some important issues 
with the new rules which result in products being excluded from the South African market. While 
local producers will be able to reformulate in li ne with the new rules, EU producers will not, for 
economic reasons. The category of "spirit aperitif" with its minimum and maximum alcoholic strength 
together with the existing minimum alcohol limits set for other "defined" classes in South Africa 
(example  whiskey) could result in a number of EU spirit drinks no longer having the right to be 
marketed in South Africa. We suggested that South Africa creates a new category "spirit drink" for 
products that do not fall under South African categories due to their  alcohol content. Without the 
flexibility that a "spirits drink " category could offer, many EU products will no longer be exportable 
to South Africa. Moreover, the European Union would like to continue the discussion on aligning the 
minimum maturation period with the one set in Cognac product specifications. We would b e grateful 
if South Africa could take these concerns into account as a matter of urgency, given the blockages 
of products. Reformulating is not an option for imported spirits, and the rules should therefore be 
adapted to allow EU spirits to be sold in Sout h Africa.  
2.276.   In response, the representative  of South Africa  provided the following statement. South 
Africa would like to confirm the receipt  of the documentation regarding the European Union and 
Mexico's STC and have met bilaterally with Mexico on the matter  at hand, including the European 
Union. After full consideration of the STCs by the EU and Mexico, including the United Kingdom, 
South Africa is off to prioritise  the matter and continue to discuss with the departments and 
regulators responsible for labell ing of alcoholic beverages regulations for the purposes of resolving 
the STC. We are optimistic that the discussion will produce concrete proposals and actions to resolve 
the STC and thereafter provide feedback to the EU, Mexico and United Kingdom. In this  regard, 
South Africa will conduct the EU, Mexico and as  well the United Kingdom to bilateral engagement as 
soon as the proposals and actions to resolve the STC is sought. Should the proposal and action be 
not sought prior next TBT Committee meeting, South  Africa shall provide the progress reports to the 
EU, Mexico and United Kingdom through bilateral means or at the next TBT Committee meeting if 
required.  
2.1.4.26   India - Pneumatic tyres and tubes for automotive vehicles, G/TBT/N/IND/20 , 
G/TBT/N/IND/20/Add.1 , G/TBT/N/IND/40 , G/TBT/N/IND/40/Rev.1  (ID 13358) 
2.277.   The representative of Indonesia  provided the  following statement. The Indonesian 
government is grateful to India for responding to the concerns conveyed by Indonesia regarding the 
 
58 For previous statements follow the thread under ID 133 . G/TBT/M/88  
 
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  policy of import restrictions on tire products at the TBT Committee meeting in July 2022. Further, 
Indonesia sent enquir ies to the Bureau of Indian Standards (BIS) through letter number 
901A/BSN/D1 -d1/09/2022 dated 1 September 2022. However, Indonesia regrets that until now it 
has not found an adequate solution to overcome these problems. The Government of Indonesia has 
studied the amendments to the tyre import policy from "free" to "restricted " issued by the 
Government of India as contained in Letter No.12/2015 -2020 issued by the Directorate General of 
Foreign Trade of the Ministry of Trade and E -Commerce India on 12 June 2 020. In addition, we 
perceive that the current import policy in India has become more stringent, where every container 
business actor sent to India needs to be sampled for customs purposes and fulfill the provisions 
related to warehouse registration where imported tyres will be stored.  
2.278.   Indonesia realize that with the enactment of this policy, importers are required to make a 
separate statement by e -mail regarding import restrictions for certain types and size categories that 
can be produced by domestic prod ucers in India and are required to fulfill warehouse registration 
requirements where violations of this will be subject to criminal sanctions under the FTDR Act 1992. 
In addition, Indonesia sees discriminatory treatment in the application of the said polic y, where the 
policy is applied selectively by targeting certain Member countries that have the potential to become 
competitors and disrupt market access for domestic tyre products. The de facto implementation of 
this policy has created unnecessary trade ba rriers in tyre products from Indonesia and limited the 
types of products that can be exported given the wide variety of tyre sizes produced in India as one 
of the world's major producers.  
2.279.   In addition, Indonesia also intends to ask for further clarification  regarding the application 
of a royalty policy or marking fee on tyre products that use the IS Mark. Indonesia is of the view 
that the imposition of the IS Mark marking fee on tyre products to be exported to third countries is 
not a common policy and has t he potential to burden business actors and create unnecessary trade 
barriers to international trade. The imposition of such marking fees has no valid justification and has 
no connection with the protection of human health, safety or prevention of fraudulen t practices. 
Indonesia views the implementation of some of these policies as inconsistent with the principle of 
non-discrimination and has the potential to create unnecessary barriers to international trade as 
stipulated in Article 2.1 and Article 2.2 of t he TBT Agreement. In this regard, Indonesia hopes that 
India can provide further clarification on the matter in question and asks India to be able to notify 
and review the implementation of the policy to ensure its conformity with the applicable provisions  
of the WTO TBT Agreement.  
2.280.   In response, the representative of India provided the following statement. India wishes to 
reiterate that its non -automatic licensing requirements for tyres are administered in a manner 
consistent with the rules of the WTO Agreem ent on Import Licensing Procedures, including with 
respect to the timeframes for the granting of import licences. Furthermore, the licensing procedure 
in question is being administered in a fair manner, as reflected in the fact that a number of licences 
have been granted following their approval by the Exim Facilitation Committee. Similarly, in previous 
meetings, India had answered the question on the marking fee charged by the Bureau of Indian 
Standards (BIS) in its Product Certification Scheme, as per the  BIS (Conformity Assessment) 
Regulation, 2018 under the BIS Act, 2016. India considers that this process is in conformity with the 
WTO's regulations, including the granting of national treatment in the way that the certification 
scheme is administered.  
2.1.4.27   China - Regulations for the Supervision and Administration of Medical Devices 
(Order No. 650 of the State Council), G/TBT/N/CHN/1022 , G/TBT/N/CHN/1023 , 
G/TBT/N/CHN/1024 , G/TBT/N/CHN/1025 , G/TBT/N/CHN/1026 , G/TBT/N/CHN/1029 , 
G/TBT/N/CHN/1313  (ID 42859) 
2.281.   The representative of the Republic of Korea  provided the following statement. The Republic 
of Korea recognizes China's efforts to protect the health of its people by enhancing the efficiency of 
supervision and management of medical devices life cycle, an d strengthening corporate 
responsibility through the Regulations for the Supervision and Administration of Medical Devices. 
However, as the Regulations are, in part, vague in its wording, Korean medical device companies 
are experiencing difficulties in tra de. Korea therefore requests China to address our concerns by 
providing clarifications. To explain in detail, in the July TBT Committee meeting, China replied that, 
and I quote, "According to article 75 of the Regulations, only the inspection institutions recognized 
 
59 For previous statements follow the thread under ID 428 . G/TBT/M/88  
 
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  by the certification, accreditation, and drug authorities can carry out the inspection of medical 
devices, " end of quote. Pursuant to Article 14 of the Regulations, China requires companies to submit 
a test report issued by a "qualified testing laboratory " when applying for marketing authorization. 
Korea would like to know if the definition or scope of "qualified testing laboratories " is identical to 
the aforementioned response China gave in the last meeting.  
2.282.   Moreover, Korea encourages China to i nclude, in its definition of "qualified testing 
laboratories, " "internationally accredited testing laboratories " that are equipped with appropriate 
facilities and manpower in accordance with relevant international standards and regulations. We 
view that ou r request is in line with China's intention to promote innovation in its domestic medical 
device industry by simplifying China's pre -market review process to enable swift market access of 
novel high -quality medical devices. To this end, as per Articles 6.1 , 6.3 and 6.4 of the WTO TBT 
Agreement, Korea requests China to include "internationally accredited testing laboratories " or 
"overseas testing laboratories " to its definition of "qualified testing laboratories. " 
2.283.   In response, the representative of China  provided the following statement. The newly revised 
Regulations on the Supervision and Administration of Medical Devices came into effect on 1 June 
2021. According to article 75 of the Regulations, only the inspection institutions recognized by 
certification and accreditation authorities and drug authorities can carry out the inspection of medical 
devices. Therefore, to carry out medical device testing, overseas laboratories can contact the above -
mentioned authorities to get the necessary qualifications.  
2.1.4.28   Indon esia - Halal Product Assurance Law No. 33 of 2014 and its implementing 
regulations, G/TBT/N/IDN/123 , G/TBT/N/IDN/131 , G/TBT/N/IDN/131/Add.1 , 
G/TBT/N/IDN/134 , G/TBT/N/IDN/139 , G/TBT/N/IDN/140  (ID 50260) 
2.284.   The representative of the United States  provided the following statement. The United States 
acknowledges Indonesia's goal to provide reliable, relevant information regarding the halal integrity 
of certain products to consumers and we have sought to work with Indonesia, bilaterally and in 
multilateral settings, since 2015 to ensure that the objective is achieved in a way that is consistent 
with Indonesia's WTO obligations. We urge Indonesia to continu e bilateral engagement with WTO 
Members and industry stakeholders. Unfortunately, many of our long -standing concerns remain 
unanswered. We refer Indonesia to our previous statement from previous TBT Committee meetings, 
as well as outstanding questions subm itted as G/TBT/W/761 . We ask Indon esia to respond to all the 
questions and concerns laid out in the Working Document and past statements. As such, we will not 
repeat all of our outstanding concerns here. Can Indonesia confirm whether there are further 
implementing regulations for the Halal  Law forthcoming, and if so, what is the expected timeline for 
notifying those regulations? We understand there may be further clarifying guidance related to 
manufacturing, storing, and transporting halal goods forthcoming. We ask that Indonesia notify 
these regulations when drafts become available, before they take effect, and take stakeholder 
comments into account before the draft regulations are adopted and implemented.  
2.285.   We understand that foreign halal certifying bodies are undergoing the process of 
accreditation. From our understanding, during this process, each halal certifying body will negotiate 
a list of products that they are able to certify with BPJPH. We have heard from industry stakeholders 
that foreign halal certifying bodies will be allowed to certify finished products, in addition to 
constituent ingredients. Can Indonesia please confirm whether foreign halal certifying bodies will be 
allowed to certify constituent ingredients and finished products? To allow US industry time to adjust 
to these n ew requirements, and to allow Indonesia time to adequately clarify and answer WTO 
Members' outstanding questions and concerns, we request that Indonesia postpone commencement 
of the Halal Law phase -in until Indonesia finalizes all of the relevant implement ing regulations related 
to the Halal Law. We remain committed to working bilaterally with Indonesia to address the 
aforementioned concerns, and those raised by other Members in this Committee, and to ensure that 
Indonesia's halal measures do not create unn ecessary obstacles to international trade.  
2.286.   The representative of the European Union  provided the following statement. The European 
Union reiterates its serious concerns on the Indonesian Halal Product Guarantee Law No 33 of 
September 2014 and its implement ing provisions, which require mandatory Halal certification and 
labelling for a very wide range of products to be placed on the Indonesian market, resulting in 
significant obstacles to EU trade with Indonesia. The EU regrets that, contrary to Article 2.9 o f the 
 
60 For previous statements follow the thread under ID 502 . G/TBT/M/88  
 
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  WTO TBT Agreement, Indonesia failed to notify to the TBT Committee the Halal Product Guarantee 
Law. As regards recent implementing provisions, the EU regrets that, on 6 January 2022, Indonesia 
adopted Regulation N° 2/2022 on International Cooperation  on Halal product assurance 
(G/TBT/N/IDN/139 ), which ente red into force that same day, before the expiration of the 60 -day 
commenting period at the TBT Committee. In a similar way, Indonesia adopted Decree 1360/2021 
on materials excluded from the Halal certification obligation ( G/TBT/N/IDN/140 ) on 27 December 
2021, even before the notifi cation to the TBT Committee on 6 January 2022, without respecting the 
period for comments.  
2.287.   Indonesia is required to notify any relevant technical measures when still in draft form and 
to leave sufficient time for comments, as provided in Article 2.9.4 the WTO TBT Agreement. In 
addition, Indonesia is required, in accordance with Article 2.12 of the WTO TBT Agreement, to allow 
a reasonable interval of no less than six months between the publication of the measure and its 
entry into force, except if this would  be ineffective for fulfilling the legitimate objectives pursued. 
The EU acknowledges the recent notifications by Indonesia of the final texts of the Regulation on 
International Cooperation and the Decree on materials excluded from Halal certification, via  
Addendum, respectively, on 27 April 2022 and 14 June 2022. The EU kindly invites Indonesia to 
provide a written reply to its comments of 12 May 2020 on Regulation 31/2018 on Processed Food 
Labelling ( G/TBT/N/IDN/124 ). The EU thanks Indonesia for the consolidated general written re ply of 
7 March 2022, at the informative session of 7 March 2022, covering several Members' comments on 
several implementing Halal measures.61 Nevertheless, we invite Indonesia to reply in writing to the 
EU specific comments for each of these measures. The EU stresses the excessive restrictive impact 
on trade of the adopted Halal law and implementing provisions, and invites Indonesia to consider  
less restrictive alternatives to the current, wide -ranging mandatory Halal certification and labelling, 
in order to pursue the legitimate objective of ensuring reliable information for consumers without 
unduly hindering trade flows. Among the main issues of concern for the EU in the Halal Law and 
implementing measures are the "non-Halal" information requested for non -Halal products or the 
extension of Halal requirements to products other than food and beverages.  
2.288.   Furthermore, in order to ensure the workabil ity of the system for foreign operators, there is 
a need for more clarity and a pragmatic approach as regards the requirements for recognition by 
Indonesia of foreign Halal certificates. In particular, the pre -condition of a specific government -to-
governme nt mutual recognition arrangement for recognition by Indonesia of foreign Halal 
certification bodies and certificates would appear unduly complex, represent an excessive burden 
for economic operators and not allow for smooth trade relations. The EU looks f orward to exploring 
more feasible and agile options with Indonesia. The EU encourages Indonesia to recognize the EU - 
Indonesia Partnership and Cooperation Agreement (EU -Indonesia PCA) as the umbrella or 
framework agreement to meet the requirements for a Go vernment -to-Government Agreement with 
the EU and its member States, in recognition of the EU as a single market of its 27 member States. 
Similarly, the EU encourages Indonesia to continue to allow Halal certification bodies (FHCBs) in a 
given EU member Sta te to certify products in other EU member States, as this is in line with the 
functioning of the EU single market. Clarification on transitional provisions for existing certificates 
would also be welcomed.  
2.289.   Meanwhile, the exclusion of end -products from the coverage of foreign certification and the 
additional registration requirement for Halal certifications of certain products by foreign Halal 
certification bodies also appears to be unjustified, costly and duplicative. In addition, the EU is 
concerned about the possibility for Indonesia to impose much higher Halal certification fees for goods 
and services from foreign business. The EU would also appreciate further clarifications on the criteria 
used for the list of materials excluded from the Halal certificat ion obligation and the procedure to 
review the list. The EU stresses the importance of ensuring the continued possibility to place non -
Halal products on the Indonesian market and urges Indonesia to review the Halal measures with a 
view at adopting a more t rade-friendly approach that does not create unnecessary obstacles. 
Notably, the EU firmly calls upon Indonesia to: - limit Halal requirements to food and beverages; - 
avoid the excessively burdensome requirement for mandatory "non-Halal" information as reg ards 
non-Halal products, and - clarify its approach to international cooperation on Halal and provide for 
 
61 (i) Draft Government Regulation (RPP) 39/2021 on Halal Product Assurance implementing the 
Omnibus Bill on Job Cr eation ( G/TBT/N/IDN/131 ); (ii) draft Decree regarding types of products and consumer 
goods to be Halal -certified ( G/TBT/N/IDN/134 ); (iii) Regulation on Halal fees ( G/TBT/N/IDN/138 ); (iv) draft 
Regulation on international cooperation on Halal product assurance ( G/TBT/N/IDN/139 ) and, (v) draft Decree 
on the materials excluded from the Halal certification oblig ation ( G/TBT/N/IDN/140 ). G/TBT/M/88  
 
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  a flexible and pragmatic process for the recognition of foreign Halal certification bodies and 
acceptance of foreign certificates, building on existin g bilateral cooperation and working 
arrangements on Halal certification, provide information on the timeline for adoption and publication 
of the remaining measures to fully implement the Halal Law. The EU reiterates its willingness to 
continue further disc ussion and cooperation on Halal issues with Indonesia, with the aim of finding 
a practical way forward and solve trade concerns.  
2.290.   The representative of Australia  provided the following statement. Australia welcomes 
ongoing discussions on the Indonesian Hala l Product Assurance Law no.33 of 2014 (Halal Law). 
Australia thanks Indonesia for the informative fourth International Halal Dialogue on 7 October 2022. 
We encourage Indonesia to continue to facilitate an open and transparent dialogue with its trading 
partners to allow foreign businesses and their valued Indonesian importers to remain adequately 
informed of the Halal Law implementation regulations. Australia would appreciate clarification from 
Indonesia on whether our existing halal assurance processes will  continue to be recognized when 
the grace period for Law 33/2014 ends in 2024. Further opportunities to engage with Indonesia's 
Halal Product Assurance Organising Agency (BPJPH) on accreditation and certification would be 
beneficial. We welcome Indonesia's  list of natural products that are exempt from the halal 
certification requirement, including fresh fruits, vegetables, grains, and some dairy products. 
Australia would appreciate an update from Indonesia as to whether it will provide an updated list of 
products that do not require halal certification under the Halal Law. It is currently unclear why some 
natural products are either included or excluded. There is also uncertainty on processed products 
and food products from animals that are not slaughtered. We would welcome an opportunity to hold 
further technical discussions with Indonesia to clarify which products are exempt from halal 
certification. Australia thanks Indonesia for their recent confirmation at the Indonesia -Australia 
Comprehensive Economic P artnership Agreement Joint Committee Meeting that this agreement a 
government -to-government agreement under the Halal Laws. We welcome further dialogue on the 
Halal Law to ensure its implementation is clear and no more trade restrictive than necessary.  
2.291.   The representative of Canada  provided the following statement. As noted previously, Canada 
would appreciate if Indonesia could provide written responses to its comment letters on 
G/TBT/N/IDN/139  and G/TBT/N/IDN/140 , as this would allow more positive and constructive 
engagement on the way forward. Without full and complete information, it will be difficult for 
Canadian exporters to ensure their production processes fully comply with all the ramifications of 
Indonesia's halal regime. Canada appreciates the information session given on 7 March 2022 by 
Indonesia th at provided answers to some of the common questions that trading partners asked 
about the Halal Product Assurance Law No. 33 and its implementing regulations. While this event 
did provide some clarity, it is understandable that Indonesia would not have bee n able to answer 
every single question posed by all trading partners in such a short timeframe. Therefore, while 
Indonesia has taken steps to clarify the scope of products that will require halal certification, 
confusion and lack of consistency remains, fo r instance with respect to HS codes for products that 
require halal certification, application of the measure to frozen seafood, and which genetically 
modified plant products may require halal certification. It is important that Canada and WTO 
Members obta in answers to these questions so its exporters can comply with the new halal regulatory 
requirements. Finally, Canada would like to remind Indonesia of its WTO transparency obligations 
to provide trading partners with adequate time and information to revie w and comment on a given 
measure, and to ensure that adequate time is provided between the publication of a final rule and 
its entry into force, so that exporters in Canada and other WTO Members can adapt, and therefore 
avoid unnecessary obstacles to trade . 
2.292.   The representative of Switzerland  provided the following statement. As in previous meetings 
of the TBT Committee, Switzerland is following this matter with interest. We share the concerns 
expressed by other Members regarding the Indonesian Halal Product Guarantee Law No 33 of 2014 
and its implementing provisions, which require mandatory Halal certification and labelling for a large 
range of products. While Switzerland recognizes Indonesia's legitimate objective to ensure reliable 
information for consumers  related to the halal integrity of certain products, we expect Indonesia to 
fully meet its WTO obligations. We believe that the Halal implementing provisions should not be 
more trade restrictive than necessary to ensure that the legitimate objectives are m et and the 
products fulfill the Halal requirements, as prescribed by the Islamic Law. Switzerland reiterates its 
concerns about the requested "non-Halal" information for non -Halal products or the extension of 
Halal requirements to products other than food and beverages. We ask Indonesia to reconsider the 
respective provisions of its recently adopted regulations. Furthermore, Switzerland refers to previous 
statements encouraging Indonesia to provide flexibility for the recognition of foreign Halal G/TBT/M/88  
 
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  certificat ion bodies and the acceptance of foreign Halal certificates. Finally, Switzerland ask 
Indonesia to notify any relevant technical measures when still in draft form and to provide sufficient 
time for comments, in accordance with the WTO TBT Agreement.  
2.293.   In res ponse, the representative of Indonesia  provided the following statement. Indonesia 
would like to appreciate and thank the United States, the European Union, Australia, Canada, and 
Switzerland for their continued interest on Halal Product Assurance Implemen tation in Indonesia. 
Indonesia once again wants to reaffirm its openness and transparency towards international 
cooperation in the Halal Assurance System based on the principle of mutual cooperation, mutual 
recognition, and mutual acceptance of conformity assessments in accordance with international 
regulations and practices. With regard to the legal umbrella for the implementation of halal 
international cooperation, Members may use any bilateral agreements in the field of political, 
economic, social, cultu ral, and any other fields, as the basis for the cooperation. Indonesia opens 
the opportunity for Members to discuss further bilaterally regarding the implementation of Law 
No. 33 of 2014 and its derivative regulations. Further, Indonesia will response all the concerns 
through formal written letter sent to the Enquiry Point of the concerned Members.  
2.1.4.29   India - Mandatory Certification for Steel Products, G/TBT/N/IND/32 , 
G/TBT/N/IND/32/Add.1 , G/TBT/N/IND/32/Add.2 , G/TBT/N/IND/32/Add.3  (ID 22462) 
2.294.   The representative of The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu  
provided the following statement. The Separate Customs Territory of Taiwan, Penghu, Kinmen and 
Matsu remain concerned about the application procedures of IS 17404:2020 (electrogalvanized hot 
rolled and cold reduced carbon steel sheets and strips) certification  under the Steel and Steel 
Products (Quality Control) Order, 2020. Since IS 17404:2020 came into force, our companies have 
faced difficulties in receiving on ‐site inspection by BIS officials due to ongoing impact of COVID -19 
and its associated quarantine p olicies. Our border controls are relaxed starting from 13 October. All 
travellers are not required for quarantine or RT -PCR test upon arrival only with seven -day period of 
self-initiated prevention. India is our fourth largest exporting market of steel pro ducts. Indian 
industry has been enjoying high quality steel and steel products from Chinese Taipei. Our 
manufacturers are ready to meet the Order. We urge the Indian government to schedule the on -site 
inspection with our manufacturers as soon as possible t o reduce the impact on bilateral trade in steel 
and steel products. We urge India to refer to G/TBT/W/774  circulated on 11 November 2022, and 
consider alternative measures to facilitate on -site inspection requirements as well as accepting 
conformity assessment results from accredited bodie s under the ILAC MRA framework.  
2.295.   In response, the representative of India provided the following statement. We thank the 
delegation of Chinese Taipei for the continued interest in this issue. At present, there is no provision 
in BIS (Conformity Assessment) Regulations, 2018, to undertake virtual inspection for conformity 
assessment activities as an alternative. As the COVID -19 restrictions have eased out, BIS has started 
carrying out inspection where confirmation for travelling of fully vaccinated BIS office rs has been 
received. To date more than 350 preliminary inspections have already been carried out. However, if 
in some cases inspection are being delayed, it is due to difficulty in getting the visa.  
2.1.4.30   China - Encryption Law of the People's Republic of China  by the Office of State 
Commercial Cryptography Administration (OSCCA) (ID 53463) 
2.296.   The representative of Canada  provided the following statement. Canada reiterates the 
following points from previous meetings of the Committee. We request a response from Chin a to 
Canada's written comments on China's State draft of Cryptography Administration's cryptography 
regulations, which Canada provided in September 2020. We also seek further clarity, transparency 
and predictability in China's regulations and laws related to Encryption and Cryptography, including 
the definition of terms; clarification that international standards will be used; and further precision 
on the measures' scope. Finally, we seek China's notification of the draft regulations to this 
Committee.  
2.297.   The representative of Japan  provided the following statement. Japan continues to have 
concerns regarding China's Encryption Law that entered into force on 1 January 2020 and would like 
to refer to the previous statement we made at the last TBT Committee in Jul y 2022. In addition, 
 
62 For previous statements follow the thread under ID 224 . 
63 For previous statements follow the thread under ID 534 . G/TBT/M/88  
 
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  China's Encryption Law has an article that prohibits requests for disclosure of source code, etc. We 
would like to request that the law prohibit not only the requests for disclosure of source code, but 
also the requests for disclosure of algorithms. Japan would like to request that China's regulation 
not hamper the activities of foreign companies or market access to China.  
2.298.   The representative of the European Union  provided the following statement. The EU would 
like to reiterate its concerns relating to the Cryptography Law that came into force on 1 January 
2020. The EU remains concerned about the wide scope of the law. These factors have already 
negatively impacted  business confidence. The EU also notes, with concern, that the new law does 
not recognize China's previous commitment, made in 2000, that the cryptography -related regulation 
would only apply to products whose core function is that of providing encryption – the so -called 
"Year 2000 Clarification" by the State Cryptography Administration (SCA). The EU calls on China to 
ensure that legal and regulatory requirements are non -discriminatory, do not favour specific 
technologies, do not limit market access and do not lead to forced transfers of intellectual property. 
The EU urges China to guarantee the possibility for foreign invested enterprises (FIEs) to participate 
on an equal footing with domestic companies in the production, research, development and sale of 
cryptography products on its market, including participation by chipmakers in standardization 
bodies, including Working Group 3 of the TC260 and the SCA's own Cryptography Industry 
Standardisation Technical Committee (CISTC). The EU requests that applicatio ns to these bodies be 
replied to in a timely manner.  
2.299.   The representative  of the United States  provided the following statement. Our concerns 
about this Encryption Law are contained in our statement on the Cybersecurity Law, so I am just 
noting that and we s upport the concerns raised by other Members.  
2.300.   In response, the representative of China  provided the following statement. The Encryption 
Law of China came into force on 1 January 2020. The law clearly stipulates that the governments at 
all levels and releva nt departments shall follow the principle of non -discrimination, and treat all 
organizations equally including foreign -invested enterprises that engage in commercial cryptography 
research, production, sales, service, import, export, etc. China encourages c ommercial cryptography 
technical cooperation on a voluntary basis and according to commercial rules in the process of foreign 
investment. Administrative agencies and their staff are prohibited to force any transfer of commercial 
cryptography technology by administrative means.  
2.1.4.31   European Union - Regulation (EC) No 1272/2008 (CLP Regulation), 
G/TBT/N/EU/629 , G/TBT/N/EU/826  (ID 53964) 
2.301.   The representative of the Russian Federation  provided the following statement. As our 
concern remains unaddressed, the Russian Federation reiterates its statements made during the 
previous meetings of the WTO Bodies with regard to the cobalt classification as a carcinogen 1b for 
all routes of exposure. We stress that this measure was adopted in the absence of sufficient scientific 
justification neither laboratory nor epidemiological one s, without taking into account grounded 
comments and opinions of the WTO Members and businesses. At the same time, we appreciate 
efforts of the EU on the adoption of the gastric bioelution protocol at the EU and the OECD levels. 
However, the EU has not ado pted this methodology and has not incorporated its use into the CLP 
Regulation as a regular practice of classifying alloys and compounds that will allow to exclude many 
cobalt -containing products from the scope of further restrictions which will be develop ed within the 
framework of implementation of this classification decision. We urge the EU to adopt this 
methodology as soon as possible. Finally, it is regrettable that the EU has chosen not to engage on 
this issue as it has been refusing to respond to pre sent concern for several meetings in a row. This 
way STCs can be hardly resolved. The situation is of systemic concern. Transparency is the important 
pillar of this organization and provision of explanations on various measures and policies in this 
Committ ee is the part of the mechanism. Refusal to respond to the raised trade concerns is in stark 
contrast to the EU's rhetoric about the importance of transparency in this organization.  
 
64 For previous statements follow the thread under ID 539 . G/TBT/M/88  
 
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  2.1.4.32   China - Cosmetics Supervision and Administration Regulation and Regulation  for 
Notification of Non -special Cosmetics, G/TBT/N/CHN/1310 , G/TBT/N/CHN/1311 , 
G/TBT/N/CHN/1331 , G/TBT/N/CHN/1453 , G/TB T/N/CHN/1454 , G/TBT/N/CH N/1459 , 
G/TBT/N/CHN/1460 , G/TBT/N/CHN/1515 , G/TBT/N/CHN/1524 , G/TBT/N/CHN/1525 , 
G/TBT/N/CHN/1526 , G/TBT/N/CHN/1527 , G/TBT/N/CHN/1539 , G/TBT/N/CHN/1615 , 
G/TBT/N/CHN/1626  (ID 57665) 
2.302.   The repres entative of the Republic of Korea  provided the following statement. Specifications 
for Cosmetic Efficacy Claim Evaluation, Specifications for Registration and filing of New Cosmetic 
Ingredients, Specifications for Cosmetic Registration and Filing , and Cos metics Supervision and 
Administration Regulation ( G/TBT/N/CHN/1526 , G/TBT/N/CHN/1528 , G/TBT/N/CHN/1524 , 
G/TBT/N/CHN/1310 ) The Republic of Korea appreciates China's response to Korea's comments on 
the Cosmetics Supervision and Administration Regulation (CSAR) and its implementing regulations. 
We hope to continue cooperation to share information on cos metic regulations. Korea reiterates our 
previous concerns as China's response remains limited to explaining how the measures are 
implemented, and as Korea's concerns were not duly addressed in China's finalized specifications 
and regulations. To begin with , China's regulations states that test reports required for cosmetic 
product registration must be issued by testing laboratories that have obtained the China Metrology 
Accreditation (CMA) certificate. In the last two TBT Committee meetings held this year, China replied 
that a number of foreign inspection institutions in China has obtained the CMA certification. However, 
Korea requests China to adopt more flexible measures by recognizing test reports issued by qualified 
foreign laboratories located outside o f the country. Second, as per Article 13 of the New Cosmetic 
Ingredients Authorization and Registration Regulation, China requires companies to prove 
equivalence of test results derived from alternative test methods to the results of in vivo  toxicity 
testing method, or animal testing. With respect to this, Korea requests China to recognize alternative 
test methods approved by the OECD or other international organizations without requiring the 
submission of equivalence evidence. Although China replied that s uch requirements are applied to 
both imported and domestic cosmetics, Korea would like to stress that our comment under this STC 
is asking China to recognize internationally approved alternative test methods in its Regulations.  
2.303.   Third, regarding the Adminis trative Measures on Cosmetic Labelling, Korea requests China 
to align its labelling requirements with international practices. In most countries, cosmetic 
ingredients are subject to declaration when the substances are at a 1% or higher concentration. 
Howev er, China's proposed regulation is not harmonized with international practices since it requires 
substances that are at a 0.1% or higher concentration to be marked, and ingredients with less than 
0.1% formula content to be labelled as "other trace ingredie nts". Fourth, China requires companies 
to specify the sources and quality data of all ingredients in their applications, which is more stringent 
than necessary compared to international practices. The required information may contain trade 
secrets and are more than necessary to fulfill China's legitimate objectives to ensure product safety 
and compliance to China's domestic market rules. Korea therefore requests China to provide an 
evidence -based explanation for its measures. Furthermore, according to Appen dix 12 -14, businesses 
are required to disclose information on ingredient safety. Korea is concerned that the mandatory 
disclosure of such information may lead to issues in the protection of intellectual property and 
commercially sensitive information. In t he last TBT meeting, China responded that trade secrets and 
intellectual property are not damaged and that trade secrets are rigorously protected. With respect 
to this, Korea requests concrete explanation on how China is protecting trade secrets. In the sa me 
vein, under the Specifications for Cosmetic Efficacy Claim Evaluation, it is still mandatory for 
businesses to disclose summarized scientific evidence that supports cosmetic efficacy claims on 
NMPA -designated websites. Since this information may contain  trade secrets that could affect the 
businesses, Korea requests China to limit such disclosure requirements. In the last meeting, China 
responded that trade secrets are protected under the Regulations on the Disclosure of Government 
Information and that th e NMPA will strictly abide by the Regulations when managing the registration 
and filing of cosmetic products. Regarding this, Korea would like to request China to provide detailed 
explanation on the measures taken to comply with its regulations.  
2.304.   The repres entative of Japan  provided the following statement. Japan appreciates China's 
response on the "Cosmetics Supervision and Administration Regulation " and its implementing 
detailed regulations in the previous meetings. However, Japan continues to express the following 
concerns as stated in July 2022, and request that China responds about the following points 
especially. 1. "Management Rules for Testing required for Cosmetic Product Registration and 
 
65 For previous statements follow the thread under ID 576 . G/TBT/M/88  
 
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  Notification, " which entered into force on 10 September 2019, stipulates that microbiological, 
physical, chemical, toxicological, and human safety and efficacy evaluation tests relevant to 
cosmetics registration and filing must be conducted by testing laboratories that obtained CMA (China 
Inspection Body and Laborato ry Mandatory Approval). China's response in the previous TBT 
Committees that many foreign -funded testing laboratories in China obtain CMA does not meet 
Japan's requirements to accept the test results of laboratories located in foreign countries. If the 
purpose of granting CMA is for confirmation of testing capability, the location is essentially irrelevant 
to testing capability. So regardless of whether the location is in China or outside China, Japan would 
like to request a more flexible framework in which  test results obtained by foreign laboratories with 
qualifications and abilities equivalent to those of CMA are accepted. 2. The "Management Rules for 
Testing required for Cosmetic Product Registration and Notification " stipulate that tests should be 
condu cted in accordance with China's national standards or relevant regulations. Moreover, the 
"Specifications for Registration and filing of New Cosmetic Ingredients " and "Specifications for 
Cosmetic Efficacy Claim Evaluation " stipulate that priority shall be given to test results in accordance 
with China's national standards or relevant regulations and that various restrictions and conditions 
are imposed in the case of conducting a test method which is not specified in the regulations. Japan 
understands the sa me restrictions and conditions are imposed on imported and domestic products. 
However, Japan would like to request that China treat internationally accepted methods such as 
those from the OECD or ISO as equal to China's national standards or relevant regul ations, so as 
not to be more restrictive than necessary in proving safety and efficacy.  
2.305.   3. Especially for the following reasons, the efficacy claim evaluation method required by the 
"Specifications for Cosmetic Efficacy Claim Evaluation " is a more stringen t requirement than 
necessary for the purpose of guaranteeing the scientific validity and reliability of efficacy claim 
evaluation and protection of consumer legal interests. Japan would like to request a flexible 
framework. "Attachment 1, Requirements of C osmetic Efficacy Claim Evaluation item " specifies four 
types of evidence. It finely stipulates which evidence could be used for each efficacy claim. However, 
the types of evidence for each efficacy claim should be judged individually by cosmetics registran ts 
and filers based on the specific wording of claims and scientific validity, as the types of evidence 
depend on the specific wording of claims. Even if a formula is very similar, the quote of "common 
efficacy claim " evaluation test data is only allowed i n exceptional circumstances such as colorants 
are different for the same registrants or filers, product lines, and multi -shades makeup products. 
Even if slight changes in a formula due to regulatory compliance are made, retests are required. 
This causes he avy burdens on cosmetics registrants and filers. Japan would like to request that 
China consider expanding the scope of the "Guiding Principles of Equivalent Evaluation ", based on 
international trends and stakeholder opinions. Regarding the evaluation test of freckle -
removing/whitening products, Japan would like to request China to adopt the approach of "Read-
Across, " which allows the evaluation test to be omitted under c ertain conditions, as was proposed in 
Article 16 (freckle -removing/whitening effect cross -reference) of the "Specifications for Cosmetic 
Efficacy Claim Evaluation (Draft for Comments) " announced in September of 2020. Freckle -
removing/whitening is affected by active ingredients included in the cosmetics and the Read -Across 
approach will help shorten the process from application to permission.  
2.306.   4. Regarding the submitting of "Cosmetic Ingredients Safety Information " issued by an 
ingredient manufacturer, Japan appreciates as an alternative proposal to solve the problem that 
China clarified after the last TBT Committee, in which it accepts Cosmetic Ingredients Safety 
Information prepared and submitted by cosmetics registrants and filers if there is the authorizat ion 
of ingredient manufacturers. However, the Cosmetic Ingredients Safety Information includes more 
detailed information than necessary for the purpose of ensuring the safety and quality of final 
products and is stricter than regulations in other countries . Requirements for such overly detailed 
information cause heavy burdens for cosmetic ingredient manufacturers or cosmetics registrants 
and filers. If the information is not submitted, it is assumed that products already on the Chinese 
market can no longer be sold or products distributed in other countries cannot be sold in China, 
possibly leading to a failure to fulfill the demands of Chinese consumers. Japan would like to request 
an adequate framework to prevent more excessive demands than necessary for a legitimate 
purpose. Especially regarding existing products for which application for registration or filing has 
occurred before 1 May 2021, which is the implementation date of registration and notification under 
the new regulatory scheme, considering the h uge number of ingredients to be covered, it is 
practically impossible to submit the Cosmetic Ingredients Safety Information by 1 May 2023. Japan 
would like to request that China provide an adequate grace period of at least one year after 
promulgation of al l relevant regulations.  G/TBT/M/88  
 
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  2.307.   5. Japan understands a transition period is set in all relevant regulations. However, we 
cannot say each transition period is long enough. Especially for existing products, Japan is concerned 
about the ability to meet the deadline for conducting efficacy e valuation tests, reporting the results, 
and changing labels. Japan would like to request that China provide an adequate grace period of at 
least one year after promulgation of all relevant regulations and guidelines, in order to prevent 
market turmoil and in order for cosmetics registrants and filers to adapt cosmetics to new 
requirements. The "Specifications for Cosmetic Efficacy Claim Evaluation " stipulate that regarding 
cosmetics for which application for registration or filing has occurred before 1 May 2021, a cosmetic 
efficacy claim evaluation must be conducted and the abstract of an efficacy evaluation of products 
must be uploaded by 1 May 2023. As mentioned in 3, considering that many conditions and 
restrictions are imposed on evaluation methods, it i s practically impossible to complete an efficacy 
evaluation of products and upload the abstract by the deadline. Japan would like to request that 
China extend an adequate grace period of at least one year. The "Administrative Measures on 
Cosmetic Labelling " stipulate that applications for registration or filing of products as of 1 May 2022, 
must be adapted to the regulations. It also stipulates that products for which application for 
registration or filing has occurred before 1 May 2022, must be adapted to the regulations by 1 May 
2023. However, registrants or filers need detailed rules and guidelines to adapt to the new cosmetic 
labelling system. Japan would like to request that China provide a grace period of at least one year 
after promulgation of all rel evant regulations.  
2.308.   6. Regarding the "Interim Measures on the Administration of Overseas Inspections of 
Cosmetics, " Japan would like to continue to request that China consider the following points. Japan 
would like to request that China clarify which laws a nd regulations are used to assess conformity 
and specific purposes for conducting foreign inspections. Japan also asks that China ensure that 
inspections will not be more trade restrictive than necessary to achieve the purpose of protecting 
human health. M oreover, information related to research and development is the most important 
confidential information for companies, and it cannot be said that it is necessarily essential 
information for product safety assurance. Furthermore, inspections within China ar e limited to the 
production sector. Therefore, Japan requests that China ensure that R&D departments that may hold 
confidential information should be excluded from the subject of foreign inspections. Japan also 
requests that confidential information will n ot be disclosed to persons other than those who are 
necessary for the legitimate purpose of the inspection. 7. The sales certification that proves the 
products have been sold on the market in the country of production is only imposed on imported 
cosmetics.  Japan requests that China treat imported products no less favourably than products 
produced in China, in other words, to abolish the obligation to acquire the sales certification that 
proves the imported products.  
2.309.   Regarding the "Administrative Measures o n Cosmetic Labelling, " which was promulgated on 
3 June 2021, Japan would like to continue to express its following concerns.  
2.310.   8. In the previous TBT Committee, China explained that the content of the Chinese labels, 
such as information regarding only produc t safety and efficacy, must be consistent with the original 
labels. Japan would like to request that China clarify that the labels stipulated by regulations of the 
country of origin do not have to be consistent with the content of the Chinese labels, inclu ding 
information regarding product safety and efficacy. 9. Article 7 requires the display of "producers, " 
"cosmetics registrants or filers " or in the case of imported products, a "responsible person in China" 
in the label. Japan has concerns that multiple company names and addresses on the label may cause 
misunderstandings on the part of consumers rather than achieving the aims of this article to inform 
consumers of the persons responsible for product quality and efficacy. In order to avoid confusion 
among consumers, Japan would like to ask that the label should indicate only a single responsible 
person ( "cosmetics registrants or filers " or in the case of imported products, a "responsible person 
in China"). Japan would like to request that China delete conte nt that requires the display of 
producers.  
2.311.   10. In the previous TBT Committee, China explained that ingredients of 0.1% or less can be 
labelled as "other trace ingredients." However, Japan is concerned about deviation from 
internationally recognized practic e. With respect to the rules for labelling of all ingredients in 
cosmetics, there is an internationally recognized listing practice that ingredients with a compounding 
amount of 1% or less are allowed to be listed in no particular order without a descripti on. Japan 
would like to request that China assure that the rules for labelling follow the internationally 
recognized practice so as not to be more trade restrictive than necessary in showing consumers the 
safety and efficacy of products. 11. The "Specifica tions for Registration and filing of New Cosmetic G/TBT/M/88  
 
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  Ingredients " and "Specifications for Cosmetics Registration and Filing " stipulate about nano 
ingredients. To follow those regulations, Japan considers that a more detailed and concrete standard 
is necessary  to judge which ingredients fall under the definition of nano ingredients. In addition, 
Japan would like to request that the standard be formulated in a way that reflects international 
trends and comments from all stakeholders.  
2.312.   12. Japan understands the pu rpose of the sample retention system explained in the previous 
meeting. Japan is not against sample retention per se. "Public notice related matters of Provisions 
for the Supervision and Administration of Cosmetics Production and Distribution " (No. 140, 20 21), 
which was promulgated on 26 November 2021, requires that, regarding products imported to China 
from foreign registrants or filers, domestic responsible persons retain samples of each batch of 
cosmetics. Foreign registrants or filers are responsible fo r the cosmetics. Japan would like to request 
that China accept that samples do not have to always be retained in China if the testing system can 
work immediately when problems with imported cosmetics occur. In addition to the above, Japan 
would like to req uest that China continue to consider the following points proposed by Japan so far:  
exemption from submitting toxicological testing documents via certification documents on the quality 
management system or good manufacturing practice qualifications; restri ct use of new toothpaste 
ingredients during the safety monitoring period only when registrants or filers confirm the use in 
advance of new cosmetic ingredients; handle an efficacy evaluation report for toothpaste by direct 
upload to the public website by r egistrants or filers in the same way as cosmetics.  
2.313.   The representative of the United States  provided the following statement. It is unfortunate 
that despite the United States and other WTO Members raising significant concerns with the 
Cosmetics Supervision and Administration Regulation (CSAR) and its implementing measures in the 
past ten TBT Committee meetings and four meetings of the Council on Trade in Goods, China has 
not sought to work with the United States and other WTO Members to reach resolution. The  United 
States maintains that it has serious concerns with CSAR and its implementing measures' likely 
inconsistency with TBT Agreement obligations, including unequal treatment for imports; overly 
burdensome and disproportionate information requirements; la ck of procedures to ensure the 
protection of confidential and proprietary information; duplicative in -country testing, and continued 
challenges with transparency. We refer to our previous two US statements for our unresolved 
concerns and questions. However , we once again raise this specific trade concern (STC) on the 
agenda today due to the pressing challenges that US industry is facing in trying to understand and 
comply with China's often unrealistic implementation timelines for CSAR and its various techni cal 
regulations, complicated even further by COVID -19 shutdowns. For example, NMPA requires product 
claims and some safety testing to be conducted at China Metrological Administration (CMA) 
accredited labs; however, many of these labs have delays of four m onths or more due to the demand 
created by CSAR filing deadlines and COVID -19 shutdowns. US companies report that their test 
samples are also getting stuck when ports shut down.  
2.314.   We understand that some NMPA provincial offices are allowing companies to appl y for 
individual product extensions, but this appears similarly burdensome, as companies must still meet 
initial CSAR deadlines and request approval for incomplete documentation. Instead, we ask that 
China consider extending by two to three years the natio nal CSAR implementation deadlines for the 
Guidelines for Cosmetic Safety Assessment (1459); Administrative Measures on Cosmetics Labelling 
(1515); Specifications for Cosmetics Efficacy Claim Evaluation (1526) and the Specifications for 
Registration and Fil ing of New Cosmetic Ingredients (1525), including extending the deadlines that 
have already gone into effect. This will allow companies a realistic timeline to implement the 
extensive new requirements introduced by CSAR and would align more closely with th e transition 
periods provided in other markets for extensive regulatory updates. We also ask that China consider 
how it can rely more upon international recognition schemes for conformity assessment to reduce 
the costs and timelines for companies to comply  with the extensive changes introduced by CSAR. 
For example, NMPA could accept claims and safety testing and documentation from overseas labs 
that are certified to good laboratory practices or good clinical practices per the ICH (International 
Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) guidelines. 
US companies have also requested a means to engage with NMPA on questions arising from CSAR 
implementation, including regarding the new requirements and use of NMPA's ne w online platforms 
for product and ingredient filings. Does China have any plans for this? We request that China 
continue to consider how these trade concerns expressed by the United States and many other WTO 
Members may be resolved in the implementation o f CSAR.  G/TBT/M/88  
 
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  2.315.   The representative of Australia  provided the following statement. Australia respects the right 
of Members to implement technical measures for legitimate policy purposes and in accordance with 
obligations under the TBT Agreement. Australia wishes to  reiterate our concerns that measures 
under China's Cosmetics Supervision and Administration Regulation (CSAR) and various 
implementing regulations, which entered into force on 1 May 2021, are more stringent and trade 
restrictive than necessary. These conc erns include testing, registration requirements, government 
certification requirements and requirements to provide detailed information on production processes 
and other aspects of their intellectual property. Australia requests that China provide a longer  
transition period for cosmetics manufacturers to consider the regulation's requirements and adjust 
their processes accordingly. Australia remains concerned that China has maintained its requirement 
for mandatory animal testing of children's cosmetics prod ucts, regardless of the level of risk 
presented by individual products. The Australian Government reiterates that we are ready to work 
with China bilaterally and to discuss the CSAR and our respective systems for cosmetics regulation.  
2.316.   The representative of  New Zealand  provided the following statement. New Zealand has 
raised this issue at the WTO on a number of occasions, including at the July 2022 meetings of both 
the TBT Committee and the Council for Trade in Goods. We welcome China's endeavours to 
moderni ze its regulatory system for cosmetics and appreciate the opportunity to comment on specific 
elements of China's regulations. We recognise China's intention to improve safety and quality 
assurance, and at the same time would like to encourage China to ensu re that facilitation of trade 
is considered in the implementation of the regulations. Our concerns in relation to China's regulatory 
system for cosmetics are well documented. In particular, New Zealand would like China to consider 
additional measures to al low for: the exemption of animal testing requirements through non -
government regulatory authority -issued GMP certification or other trade facilitative mechanisms for 
providing product assurances; providing flexibility in respect of product testing requirem ents. In 
particular, we encourage China to accept test reports from accredited laboratories situated outside 
of China; and further limitations on product disclosure requirements, particularly in relation to 
sensitive information, i.e. limited to that which  is required to assure product safety in China's 
domestic market, so as not to compromise intellectual property. New Zealand appreciates our recent 
constructive bilateral engagement on cosmetics issues and looks forward to engaging further with 
China on it s Cosmetics Supervision and Administration Regulations (CSAR) to address these issues.  
2.317.   The representative of the European Union  provided the following statement. The EU would 
like to support the delegations of Republic of Korea, Japan, the United States, A ustralia, and New 
Zealand. The EU would like to refer to its earlier statements on this topic, as the EU's concerns 
outlined therein remain unchanged. The European Union supports CSAR's objective of ensuring 
consumer safety. However, CSAR and its various i mplementing regulations are more stringent than 
necessary to ensure the safety and quality of imported cosmetics. The CSAR's requirements go far 
beyond what is necessary to ensure consumer safety and traceability of the ingredients used in 
cosmetics. It is  also diverging from international practice, as such an extensive level of information 
is not required elsewhere in the world for notification and registration purposes. The obligation to 
transmit confidential information on new products and their ingredie nts to Chinese authorities 
remains one of EU's most important concerns. According to the EU, the mandatory disclosure of 
commercially sensitive information required in the notification and registration process, touching on 
intellectual property rights (IPR ) of companies involved, goes far beyond what is required in line 
with internationally recognized practices. Chinese measures pose significant risks to companies' 
intellectual property and commercially sensitive information and are not proportionate to the  
objectives sought.  
2.318.   Regarding the Specifications for Cosmetic Efficacy Claim Evaluation, the EU cosmetics 
manufacturers are required to make public a detailed summary of efficacy evaluation, which can 
reveal business -sensitive information. Additionally, fo r certain efficacy claims (sunscreen, skin 
whitening/spot removal, and anti -hair loss), it is still mandatory to use specified Chinese test 
methods. Such tests must be carried out by specific testing institutions in China. Furthermore, for 
new efficacies, if methods are not yet established in China, they must be validated in at least two 
qualified testing institutions in China, to be used to support an efficacy claim in China. The multiple 
China -specific requirements for efficacy testing will require signif icant re -testing of products for 
which the efficacy was already established in a third country. This affects also many thousands of 
products that already have been placed on the market in China and for which the claim substantiation 
still needs to be compl eted. G/TBT/M/88  
 
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  2.319.   In response, the representative of China  provided the following statement. Requiring the 
inspection for cosmetics registration and notification to be carried out by professional institutions 
aims to protect consumers' rights and ensure the accuracy o f the inspection results. Inspection 
institutions shall obtain the certification of inspection and testing qualification (CMA) in the field of 
cosmetics. China does not prohibit foreign inspection institutions from getting the certification, and 
China's Ad ministrative Measures for the Accreditation of Inspection and Testing Institutions do not 
restrict foreign inspection institutions from getting such certificates either. Based on the non -
discrimination principle of the WTO, the Provisions on the Administra tion of Cosmetics Registration 
and Notification Data put exactly the same requirements on imported and domestic ordinary 
cosmetics regarding the alternative program to animal tests for safety evaluation. For both domestic 
and imported ordinary cosmetics, t he toxicological test can be replaced with a safety risk assessment 
once they have obtained quality management system certification issued by government authorities. 
The formulation of the specifications for the Evaluation of Cosmetic Efficacy Claims is to  further 
ensure the scientificity, accuracy, and reliability of the evaluation of cosmetics efficacy claims, 
safeguard consumers' rights, and promote social co -governance and healthy development of the 
cosmetics industry. The Regulations on the Supervision  and Administration of Cosmetics and the 
specifications for the Evaluation of Cosmetic Efficacy Claims and other supporting regulations clearly 
require that the claims of cosmetic efficacy should be based on sufficient scientific evidence. Based 
on the pri nciple of equivalence, the test method of efficacy claim evaluation does not make many 
limitations in selecting the evaluation methods. Cosmetic registrants may, by themselves or through 
entrusted competent evaluation institutions, carry out cosmetic effic acy claim evaluation according 
to relevant requirements set in Cosmetic Efficacy Claim Evaluation Project Requirement and 
Technical Guidelines for Cosmetics Efficacy Claim Evaluation. The specific requirements for the 
equivalent evaluation of freckle remov al and whitening efficacy have been clearly defined by the 
contents of "equivalent evaluation of efficacy claim " in relevant documents.  
2.320.   The information of cosmetics manufacturers includes the relevant information of the 
manufacturers and their locations, e tc. Requiring information about manufacturers is important for 
protecting consumers' right to know, as well as for promoting social co -governance and cracking 
down on counterfeiting and shoddy products. The Regulations on the Supervision and Administration  
of Cosmetics clearly stipulates that the registrant of cosmetics is responsible for the quality and 
safety of cosmetics. The Measures for the Administration of Cosmetics Labels stipulates that 
ingredients with weight percentages not exceeding 0.1% (w/w) s hould be labelled with "other trace 
ingredients " as indicating words. No descending order of ingredient content or any other specific 
order is required. Product safety is closely related to the safety of raw materials. It is important for 
ensuring product safety to require registrants to clarify the relevant information on raw materials 
safety when applying for registration. Considering that it is common for enterprises to change the 
raw material manufacturer, the Provisions on the Management of Cosmetics R egistration and 
Notification Data make corresponding requirements according to different circumstances in which 
the raw material manufacturers of registered or notified products have changed: if the content of 
the raw materials used in the formula and the type and proportion of ingredients in the raw materials 
have not changed, it only needs to maintain the raw material manufacturer through the registration 
and notification information platform; if the content of raw materials in the formula and the content  
of main functional ingredients and solvents in the raw materials stays the same, and only the type 
or content of minor stabilizer, antioxidant, preservative and other ingredients added to ensure the 
quality of raw materials has changed, then only the chan ge-related information shall be submitted, 
not all the information. In order to facilitate the cosmetics registrant to supply the raw material 
safety -related information, it is made clear in the Regulations on the Administration of Cosmetics 
Registration a nd Recordholder issued by the State Food and Drug Administration that if the raw 
material manufacturer has already submitted the raw material safety -related information according 
to the regulations, the registrant only needs to fill in the raw material sub mission code for 
information association.  
2.321.   The procedures and data requirements for the registration and notification of cosmetics and 
new raw materials are detailed and clear in relevant regulation papers. Requiring registrants to 
submit safety -related mat erials is also a common practice aiming at the safety review of health -
related products. It is exactly for the purpose of protecting the intellectual property rights and trade 
secrets of enterprises that the evaluation data required of cosmetics efficacy c laims only include the 
summary of the supporting material of the efficacy claims rather than the full text. The required 
technical materials of new raw materials only cover the basic aspects, such as the name, registration 
number, source, composition, phys ical and chemical properties, the purpose of use, the scope of 
use, safe amount of use, precautions, storage conditions and best before period, rather than the G/TBT/M/88  
 
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  complete information. The authorities and administrative staff will strictly protect trade secre ts in 
handling cosmetics registration, as ordered by all relevant laws and regulations.  
2.1.4.33   European Union - Medical Device Regulation (MDR) and In Vitro Diagnostic 
Medical Devices Regulation (IVDR), G/TBT/N/EU/71/Add.1 , G/TBT/N/EU/72 , 
G/TBT/N/EU/72/Add.1 , G/TBT/N/EU/845  (ID 59466) 
2.322.   The representative of China  provided the following statement. China appreciates the EU's 
efforts in promoting the implementation of in vitro  diagnostic medical devices, however, the EU has 
not designated the relevant reference laboratories to undertake perf ormance verification, which will 
have an impact on the certification and marketing of Class D products. We suggest the EU issue the 
list of reference laboratories as soon as possible. It is also recommended to extend the application 
time of (EU) 2022/1107 by at least one year from 25 July 2024, or to issue an alternative 
enforcement guide or detailed rules without reference laboratories.  
2.323.   The representative of Japan  provided the following statement. 1. Since the MDR's 
implementation dated 26 May 2021, Japane se manufacturers have been unable to ship new products 
and medical devices with new features to Europe. In the previous meetings, Japan stated, "several 
companies continue to inform us that not much improvement seems to have been made in the more 
than two years and three months that have passed since the technical document review started. We 
would like to request that the EU continue to monitor and make improvements as a regulator." Japan 
appreciates the EU's response at the last meeting that the MDCG (Medi cal Device Coordination 
Group) is closely monitoring the situation of the reviews on the ground. However, we are still hearing 
from several companies that not much improvement seems to have been made in the more than 
two and a half years that have passed s ince the technical document review started. Japan would like 
to request that the EU continue to monitor the situation and make improvements as a regulator. 
The expiry date of MDD certificates is 26 May 2024. Products with MDD certificates can also be 
placed on the market or put in use until 27 May 2025. In view of the delayed certification of the 
MDR, Japan requests that these expiry dates be extended by one year to 26 May 2025 and 27 May 
2026, respectively. Products with a certificate expiry date before 26  May 2024 under the old directive 
cannot be placed on the market or put in use after the certificate expiry date under the old directive, 
in accordance with Article 120 (2) of the MDR / Article 110 (2) of the IVDR. Therefore, in order to 
solve this problem , Japan requests the EU to introduce interim measures that would allow these 
certificate expiry dates to be extended by the period spent by the notified bodies for the technical 
document review (from the application date to the certification date), or be e xtended by a certain 
period, provided that there are no significant changes in the design or intended use of the products 
concerned.  
2.324.   2. Japan appreciates the sequential publication of the guidance in line with the MDCG 
Guidance Publication Plan. In line wi th our statements in the previous meetings, Japan requests that 
public consultation be carried out prior to the publication of MDCG guidance, and that the published 
MDCG guidance have a transitional period, and that it be used for reviews by notified bodie s after 
the transitional period has elapsed. Though guidance on post -marketing surveillance and vigilance 
is also included in the publication plan, Japan requests prompt publication. Japan also requests that 
the mapping of the EMDN (European Medical Device  Nomenclature) and the GMDN (Global Medical 
Device Nomenclature) is achieved through the EU's active involvement in the WHO's standardized 
nomenclature for medical devices. 3. Strict clinical evaluation is required even for relatively low -risk 
medical devi ces classified as Class I, IIa and IIb under the MDR. Japan requests that the EU consider 
simplifying the clinical evaluation requirements for low -risk medical devices like Japanese 
pharmaceutical certification or US 510(k) regulations also from the viewpo int of promoting 
international harmonization. As requested in the previous meetings, Japan continues to request that 
the EU consider ensuring that the operation of this is not more trade -restrictive than necessary. 
4. In the previous meetings, Japan stated  "The publication plan in the EU Official Journal on 
harmonized standards is not disclosed and they are promulgated abruptly. Therefore, Japanese 
manufacturers need to develop and respond to their conformity plans urgently after the publication 
of harmoniz ed standards. We request the release of the plan for the development and publication of 
harmonized standards for the MDR and IVDR." Japan requests continued consideration on the 
publication plan and setting an adequate transition period for the MDR and IVD R harmonized 
standards.  
 
66 For previous statements follow the thread under ID 594 . G/TBT/M/88  
 
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  2.325.   5. As stated in the previous meeting, Japan welcomes the extension of the transition period 
for three to five years beyond the date of 26 May 2022 that the IVDR entered into force, for IVD 
products requiring certification by a notif ied body, depending on the risk classification of the device, 
as a result of Regulation (EU) 2022/112 entering into force. However, we are still deeply concerned 
that many manufacturers will not be able to complete certification by the deadline. The result s 
obtained by the survey on IVDR certification status conducted by the Japan Association of Clinical 
Reagents Industries in June 2022 for Japanese IVD manufacturers revealed that 12% of IVD devices 
requiring IVDR certification have been certified, 25% of I VDs are under review, and 63% of IVDs 
are yet to start being reviewed. In particular, about 80% of Class B devices, which account for about 
70% of all devices requiring certification, have yet to start being reviewed. Regarding the review 
period, the surve y revealed that there have been cases where certification has not been received 
even after 20 months have passed, and more than 70% of companies have experienced delays in 
certification reviews compared to their original plans. Considering these results an d the fact that 
there are only seven notified bodies for the IVDR as of September 2022, Japan still has concerns 
about the lack of infrastructure necessary for certification. Therefore, Japan would like to request 
that the EU make a continuous improvement in the capacity of notified bodies, including an increase 
in the number of notified bodies, so that certification can be conducted promptly. Meanwhile, the 
number of guidance documents related to the IVDR has steadily increased since the last TBT 
committee  in July, with the publication of two new documents in September, bringing the total to 
ten documents. Japan would like to express our deep appreciation for the effort of the MDCG in this 
regard. Japan continues to request the MDCG to further expand the gu idance documents and indicate 
their availability as soon as possible. Japan also continues to request that newly published guidance 
documents not be used for reviews by notified bodies immediately after publication, but that there 
be a transition period of  at least one year.  
2.326.   The representative of the United States  provided the following statement. The United States 
appreciates the European Union's (EU) continued efforts to apply a robust regulatory framework to 
ensure the safety of medical devices. Many of our concerns from the last meeting remain. Industry 
continues to inform us that serious implementation hurdles remain that are creating an unpredictable 
market environment for medical technology manufacturers. These manufacturers report that 
implementation  remains slow, with long delays in securing certificates of compliance. The EU 
continues to have a lack of sufficient capacity to assess conformity to the MDR in a timely manner. 
Additionally, with a lack of capacity to assess conformity to MDR even for ex isting devices already 
on the market, MDR -designated Notified Bodies do not have the capacity to evaluate new products 
in a timely manner. We reiterate that we have heard that some companies are considering 
deprioritizing the EU market as the geography of choice for first regulatory approval of new devices. 
Has the EU Commission taken any further steps since the last meeting to speed up the conformity 
assessment process and to resolve the backlog of devices awaiting certification? Have any of the 
recommenda tions provided by the Medical Device Coordination Group (MDCG) been implemented? 
The United States welcomes the implementation of the MDCG recommendations but believes the 
measures, while positive, would fall short of solving the problem. Is the Commission  considering any 
of the legislative fixes that have been proposed by EU member States?  
2.327.   We ask the Commission if it has made any additional resources or flexibilities available to 
currently approved Notified Bodies since the last meeting to ensure these Not ified Bodies have 
sufficient resources to meet existing demand? If so, what resources are being provided? We also 
once again would like to raise issues with the European Medical Device Nomenclature (EMDN) 
system. Last time we discussed MDR/IVDR implementat ion with the EU, the EU stated that there 
was confusion about the UDI and nomenclature system. The United States respectfully disagrees 
with this statement. Article 26 of MDR mandates that the Commission is to ensure that an 
"internationally recognized med ical device nomenclature " is available to manufacturers. The United 
States appreciates that the EU based its UDI system on the IMDRF UDI guidance, but it failed to 
select a nomenclature system that is internationally recognized – an obligation specifically  outlined 
in Article 26 of MDR. The EU also has said on the floor that it chose EMDN because it "was founded 
on the need for a sensibly structured nomenclature that is transparent, open, completely publicly 
accessible and downloadable for free. " The United  States would like to remind the EU that, contrary 
to EMDN, which was based on a nomenclature that was developed for procurement, GMDN was 
developed with the support of ISO and the then -Global Harmonization Task Force (now the 
International Medical Device Regulators Forum) and is widely adopted by the medical device industry 
and used by over 100 national medical device regulators to support their activity. GMDN is free and 
accessible to all and has been since the selection of EMDN. To maintain the strong pr esence of 
lifesaving medical technologies currently in the European market and broaden the range of new, G/TBT/M/88  
 
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  innovative technologies that are able to enter, the United States implores the European Commission 
to swiftly put solutions in place that resolve these  ongoing challenges.  
2.328.   The representative  of Australia  provided the following statement. Australia supports the 
concerns shared by other Members on this issue and would like to refer the European Union to our 
previous statements made to the Committee.  
2.329.   In res ponse, the representative  of the European Union  provided the following statement. As 
announced in previous Committee meetings, the MDR officially entered into application on 26 May 
2021. It is important to remind Members that the shift between the Directiv es to the MDR is a 
gradual one, facilitated by a grace mechanism that allows for medical devices in compliance with the 
Directives to continue to be in circulation until May 2025, in parallel with MDR -certified devices. As 
regards the IVDR and as of May 20 22, a staggered set of transition periods for IVDs was proposed 
by the European Commission. The proposed amendment to the IVDR has since been agreed upon 
by the European Parliament and Council. A measure explaining the adapted transitional provisions 
was a lso notified to the TBT Committee. The length of the transition periods depends on the risk 
class of devices, with shorter transition periods for higher risk devices and longer periods for lower 
risk devices. In addition, the notified draft proposes a defe rred application of the requirements for 
"in-house devices", i.e., those made and used within the same health institution. We are happy to 
report that as of today, we now have 34 MDR -designated Notified Bodies and seven Notified Bodies 
under the IVDR, whic h is eight more since our last update. Furthermore, two additional NBs are 
expected to complete their designation process under MDR by the end of 2022 and one more under 
IVDR, latest by January 2023.  
2.330.   The European Commission is fully aware of the challenges  related to the implementation of 
the new Regulations on medical devices, and regularly cooperates with the EU member States, 
stakeholders and all interested parties, in particular in the Medical Device Coordination Group 
(MDCG), to address the concerns of  economic operators and envisaging concrete measures to 
improve the situation. In August 2022 the MDCG adopted a Position Paper entitled Transition to the 
MDR and IVDR - Notified body capacity and availability of medical devices and IVDs (MDCG 2022 -
14) (wh ich is available online) with a number of concrete and specific actions aiming at addressing, 
among others, the issue of capacity of notified bodies and availability of medical devices and in vitro  
diagnostic medical devices, and propose pragmatic approach es within the application of the current 
legal framework. The MDCG will continue to closely monitor the situation on the ground and has 
established regular contacts with Notified Bodies and industry in that regard. The Commission 
remains attentive to conce rns expressed and is aware of requests by member States and 
stakeholders for additional measures beyond those included in the MDCG position paper MDCG 2022 -
14. The Commission will present clear orientations on the solutions at the next Health Council in 
December, as agreed by health ministers when the matter was last discussed in the Health Council 
in June.  
2.331.   To date, there have been more than 100 published guidance documents, including several 
key guidance on the transitional provisions and clinical requirem ents. In addition, the most recent 
milestone is the positive opinion on the Commission Implementing Regulations on common 
specifications for products listed in Annex XVI of (EU) 2017/745 and on rules for the application of 
MDR as regards reclassification o f groups of certain active products without an intended medical 
purpose. As regards the Unique Device Identification (UDI), allow us to underline the fundamental 
difference between the UDI and the Nomenclature, which are two topics that seem to be intermix ed. 
While the UDI system employed in the EU is based on internationally agreed -upon principles, the 
Nomenclature, also known as the language of use, is different. In the views of the EU, a 
nomenclature is viewed similar to a dictionary, where unlimited acc ess only empowers users, 
patients, regulators and all other actors. The decision to move forward with the Italian National 
Classification for medical devices (CND) as a basis for the European Medical Device Nomenclature 
(EMDN) was not taken lightly but onl y after careful and extensive assessments and consideration by 
EU member States, jointly with the Commission. Data from 2019 shows that the CND was already 
implemented by three EU member States (Italy, Portugal and Greece) and utilized by over 15,000 
manuf acturers from both EU and non -EU countries.67 The EU is proud to have a nomenclature that 
is publicly available in its entirety and has a consultation mechanism open to all. In this open system, 
all codes, terms and hierarchical structures are completely p ublicly available and downloadable for 
free. There are currently no other nomenclature systems offering these characteristics. It is 
 
67 md_cnd_general_principles_en_0.pdf   (europa.eu)   G/TBT/M/88  
 
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  important to reiterate that the choice of this nomenclature does not constitute a barrier. The EU is 
fully committed to ens uring that the new system provides a higher level of patient protection and 
counts on trade partners to encourage their manufacturers to meet these new requirements to 
ensure trade continuity.  
2.1.4.34   Qatar - Ministry of Public Health Circular regarding shelf life for cheese (ID 
60268) 
2.332.   The representative of the European Union  provided the following statement.  The European 
Union would like to refer again to the Qatar's Ministry of Public Health Circular of 30 May 2019 
establishing new import requirements for UH T milk and white cheese that entered into force already 
in 2019. The scope of these measures was further expanded with Qatar's Council of Ministers 
instructions issued in August 2021. Regrettably, these measures affected several dairy products 
exported fro m the EU to Qatar and the European Union would like to recall the importance of 
addressing these concerns. During the TBT Committee meeting in March, Qatar informed that the 
Circular had been suspended, while awaiting an internal review process. On 28 Apri l 2022, Qatar 
approved a new Circular, which removed some of the proposed restrictions on the shelf life of dairy 
products. However, these were re -introduced a few days later, on 1 May 2022, by a new Circular. 
We understand that both Circulars are currentl y applicable. In general, the EU is concerned about 
the lack of predictability on the rules that operators need to follow, as well as on the shelf lives 
introduced which are unnecessarily trade restrictive and are not following the international 
standards.  We would like to appreciate the meeting we had with Qatari authorities in June and 
September 2022, where we discussed the matter and Qatar indicated it was assessing and re -
evaluating the situation of dairy imports and preparing a comprehensive study on t he subject. In 
this context, we would appreciate information on results of such an assessment and the state of play 
of the said study. At the same time, we would like to urge Qatar to adopt a permanent solution and 
to withdraw the current trade restrictive  measures and to put in place trade measures in line with 
the WTO requirements. In this respect, the European Union would like to insist on the need to notify 
any proposed measure at a draft stage to this Committee. The European Union is grateful that we 
had further constructive exchanges with Qatar on this matter, where Qatar signalled to be working 
on a solution to be offered in a near future. We stand ready to continue to work constructively with 
Qatar to resolve this important issue in due course.  
2.333.   The representative of New Zealand  provided the following statement. New Zealand continues 
to have concerns with Qatar's shelf -life requirements for imported cheese and other dairy 
commodities as these are trade restrictive, not based on science and not in line with Codex 
standards. New Zealand continues to request that Qatar use internationally recognised standards 
such as Codex for the setting of shelf -life requirements.  
2.334.   The representative of the United States  provided the following statement. The United States  
supports the interventions of the EU and New Zealand.  
2.335.   In response, the representative of Qatar  provided the following statement. Qatar has taken 
note of the continued concern of the European Union, New Zealand, and the United States regarding 
Qatar's Mini stry of Public health circular on quality standards for certain dairy products and thanks 
them for their interests in this matter. Qatar has been holding discussions on this matter with the 
European Union where many issues have been clarified and would con tinue these constructive 
discussions. Last meeting was held on 3 November. As it has been clarified, these measures have 
been initiated by the Ministry of Public Health with a view to ensuring the quality of products available 
in Qatar. The protection of c onsumers is of primary importance to the Government of the State of 
Qatar in accordance with our international obligations. We would like to assure Members that the 
relevant measures apply equally to domestic and imported products and are therefore non -
discriminatory in nature. Furthermore, any impact that such regulations may have on trade will not 
be more than necessary to contribute to the fulfillment of the legitimate objective of protecting 
consumers. In this respect, we would like to emphasize that pr oduct -specific requirements applied 
in the State of Qatar do not prevent the importation and sale of any products that meet quality 
standards and thus do not have a significant effect on trade. This being said, we have listened 
carefully to the concerns ex pressed by the European Union and New Zealand today and will again 
share them with our capital. Also, we remain available to continue our constructive discussion with 
 
68 For previous statements follow the thread under ID 602 . G/TBT/M/88  
 
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  the European Union and any other interested Members to provide additional explanation whe re 
necessary.  
2.1.4.35   India - Air Conditioner and its related Parts (Quality Control) Order, 2019, 
G/TBT/N/IND/74 , G/TBT/N/IND/110  (ID 59869) 
2.336.   The representative of China  provided the following statement. With this concern, China 
would like to suggest the following for India's consideration. Enhance the efficiency of factory audits, 
and guarantee the smooth conduction of overseas factory inspections. Further postponement o f the 
entry into force of the air conditioner QCO in view of the impact on supply chain and travel limitation 
because of the COVID -19 pandemic. Provide alternative measures during the pandemic, such as 
temporary factory audit exemption for a limited period  or virtual audit, or conducting audits through 
third-party agencies, to address the difficulties with physical inspection due to international travel 
restrictions.  
2.337.   In response, the representative of India provided the following statement. India thanks 
China for its continued interest in this issue. We would like to reiterate that sufficient capacity for 
testing room air conditioners is available with the Bureau of Indian Standards recognized 
laboratories. The Bureau of Indian Standards, under its laborator y recognition scheme (BIS LRS), 
grants recognition to laboratories for testing of products as per the relevant Indian Standards. Clause 
12 of BIS LRS deals with the recognition of overseas laboratories. The decision regarding recognition 
of overseas labora tories is taken by BIS taking into account the MRA (Mutual Recognition Agreement) 
with the concerned countries. At present, there is no provision in BIS (Conformity Assessment) 
Regulations, 2018, to undertake virtual inspection for conformity assessment ac tivities as an 
alternative. As the COVID -19 restrictions have eased out, BIS has started carrying out inspection 
where confirmation for travelling of fully vaccinated BIS officers has been received.  
2.1.4.36   China - Draft Administrative Measures for Registration of  Overseas Producers of 
Imported Foods, G/TBT/N/CHN/1522  (ID 61170) 
2.338.   The representative of Canada  provided the following statement. Canada and other Members 
continue to raise significant concerns and challenges with China's administrative measures for the 
registration of overseas m anufacturers of imported food. Canada would like to refer to its previous 
interventions on this item, which remain valid. Canada continues to be concerned that the new 
administrative measures are overly burdensome and unjustified. These measures are broad and 
overarching in scope and will have a significant impact on Canadian exports to China. Canada notes 
that the implementation of the online China Import Food Enterprise Registration (CIFER) system, 
which was not notified by China to the WTO, is unnecessar ily having a negative impact on trade, 
which includes significant financial and resource impacts on both industry and foreign competent 
authorities. As an example, China's registration and approval process in CIFER requires both the 
foreign competent autho rity and Customs China to manually review and approve the information 
submitted by companies in CIFER. This requires the allocation of significant resources by foreign 
competent authorities and causes delays in the registration update and renewal process f or 
companies seeking to export to China.  
2.339.   The registration process in the CIFER system is confusing, substantially hindered by ongoing 
technical challenges, and lacks clear guidance and defined timelines for both competent authorities 
and industry. Despite repeated requests from trading partners, there remains limited engagement 
or guidance from Customs China regarding the implementation of the CIFER system, which is 
resulting in continued uncertainty and concerns by trading partners. Canada notes that after  
repeated attempts, none of the Canadian fish and seafood establishments, whose CIFER registrations 
will expire on 31 December 2022, have been able to successfully obtain approval from Customs 
China for their applications. Canada strongly urges China to co mmunicate all timelines and decisions 
related to its review and approval process in CIFER in a transparent manner. Canada urges China to 
develop clear guidance documents to address the questions and concerns from both industry and 
foreign competent authori ties. As many questions remain regarding the CIFER registration process, 
Canada calls on China to create separate contact points within Customs China for both industry and 
foreign competent authorities, or to work directly with companies for the completion  and renewal of 
their registrations in CIFER. Canada remains deeply concerned about the impact these measures are 
 
69 For previous statements follow the thread under ID 598 . 
70 For previous statements follow the thread under ID 611 . G/TBT/M/88  
 
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  having on trade and recalls that in October 2021, China stated that Decrees 248 and 249 and CIFER 
would not impact trade. Therefore, Canada as ks that China commit to improving the efficiency of its 
registration approval process in CIFER to ensure that trade is not disrupted. In conclusion, Canada 
calls on China to provide Members with additional information, clarification and flexibility on the 
requirements under the measures and the CIFER system immediately to avoid further delays in the 
registration process for Canadian companies and prevent unnecessary trade disruptions.  
2.340.   The representative of Kenya  provided the following statement. China 's Cus toms agency 
issued new regulations affecting overseas manufacturers of foods that export to China on 12 April 
2021. Kenya is concerned that some provisions in the regulation are more trade restrictive than 
necessary contrary to Articles 2.2 of the TBT Agre ement as follows . The regulation imposes new 
obligations for the government agencies of the foreign nation/region by wading into their regulatory 
autonomy. According to the Regulations, all overseas manufacturers of foods that export to China 
are required to register with China 's General Administration of Customs (GACC). The foreign food 
facility registration requirements established are cumbersome and are likely to pose major trade 
disruptions by mandating documentation and procedures beyond what is curren tly required for 
higher -risk products; hence making it more difficult for small and medium enterprises to integrate 
into the global value chains. Kenya therefore urges China to review these regulations, and possibly 
revise them to provide among other thing s, clarity on the scope of their application (transparency), 
and make them less stringent to comply with , i.e. eliminate the need to have all imported food and 
food products to be pre -registered with China 's General Administration of Customs (GACC).  
2.341.   The re presentative of Australia  provided the following statement. Australia would like to 
reiterate our concerns with China's the implementation of measures under Decree 248. We have 
raised these concerns in previous TBT meetings, including most recently in July  2022. Australia 
acknowledges China's efforts to facilitate implementation of measures under its Regulation on 
Registration and Administration of Overseas Manufacturers of Imported Food (Decree 248). Australia 
nonetheless remains concerned at the resource -and-labour -intensive cost of changes within China's 
registration system – costs which are borne by exporting countries' competent authorities. Exporters 
continue to face delays and suffer from a lack of clarity surrounding the registration of food 
enterpri ses within China's registration systems. Delays in processing registration renewals and new 
applications from overseas food producers may lead to imported foods being treated less favourably 
than China's domestic products. Australia is also concerned with the provision under Decree 248, 
which allows China to livestream audits of foreign food facilities at short notice and threaten 
suspension for non -compliance. Australia would like to request that China meets its obligations to 
provide Members with: transpa rent timeframes for updates and processing of applications, in line 
with obligations under the TBT Agreement appropriate guidance and assistance to support 
enterprises in meeting China's registration processes, and consideration of the difficulties the 
systems pose to applicants and the need for additional time to address these difficulties. Australia 
urges China to address these issues promptly and remains willing to work bilaterally with China to 
minimize trade disruptions.  
2.342.   The representative of Japan  provided the following statement. Japan would like to reiterate 
its concerns regarding the implementation of Decree 248 by China. The procedures remain uncertain 
and lack predictability; in particular, frequent, unexpected changes have been made to the China 
Import Food Enterprise Registration (CIFER) system without prior notice to the Members. As a result, 
the operation of Decree 248 could have a significantly negative impact on China's trade with Japan 
and other Members. Japan requests that China improve the  operation of the CIFER system, and also 
make the procedures for implementation of Decree 248 transparent, based on the Members' remarks 
at this and previous TBT Committee meetings. Specifically, Japan requests that China: (i) Establish 
a standard processi ng period for applications made through the CIFER system (i.e., a standard 
timeline to be followed from application through registration), and make that processing period 
known to the Members and foreign manufacturers. (ii) Notify the Members promptly of a ny changes 
in the operation of the regulations or the CIFER system, including changes to product codes (HS  CIQ) 
used in the system, which will or might affect exports. Should any changes occur, we also ask that 
GACC provides a reasonable transitional perio d. (iii) Correct any defects in the CIFER system before 
the end of this year, including: (a) the fact that the system does not accept changes to information 
about the legal representatives and addresses of registered manufacturers and does not accept the 
submission of letters of proxy; (b) the current, considerable delays in the registration process; and 
(c) the fact that some of the product codes (HS CIQ) are missing from the list shown on the system. 
(iv) Establish an Enquiry Point for interested parties and competent authorities, and also hold an 
information session by the end of this year in Geneva for concerned Members regarding G/TBT/M/88  
 
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  implementation of the regulations. (v) Respond to unanswered questions within a reasonable time. 
Japan thanks China for its pr ompt attention to resolving these issues in an appropriate and timely 
manner.  
2.343.   The representative of the European Union  provided the following statement. The EU must 
raise this topic again to highlight remaining concerns about the implementation of Decree 2 48 of the 
General Administration of Customs of the People's Republic of China (GACC). The EU does not 
question the right of China to ensure that imported food products come from legitimate sources. 
Overall, we share and support this objective. However, EU applicants are still facing many issues in 
the registration process, mostly due to the web -based registration system (CIFER), which still has 
numerous technical problems, making the electronic submission of documents cumbersome, time 
consuming and uncertai n. Adding to this difficulty, the Customs Administration recently informed EU 
member States that certain product categories would be exempt from the registration procedure 
that had previously been included under Article 7 of Decree 248. However, GACC does not clearly 
identify these products. Due to the unclear scope of the registration and the numerous technical 
issues with CIFER, EU member State authorities are facing massive difficulties implementing Decree 
248. Competent authorities and businesses must c onsult the CIFER database almost continuously 
to follow individual registrations and react to unforeseen issues. To avoid food trade disruption, we 
request that existing approvals remain valid until the renewal process under Decree 248 is properly 
establis hed. Under the current circumstances, it appears impossible to complete the registration 
process under Article 7 by the deadline foreseen, which is June 2023.  
2.344.   The EU urges China to: Provide clear guidance and supporting materials on products falling 
under Article 7 of Decree 248 and on procedures applicable to products which are not covered; 
Simplify the data entry and resolve the software problems with the CIFER system; Facilitate 
amendments/corrections and follow -up to ongoing registrations; and Extend th e deadline of June 
2023 given the technical problems relating to the registration system and because it is unlikely that 
all establishments falling under Article 7 of Decree 248 will be able complete their registration on 
time. The EU would like to thank C hina for the dialogue so far which helped to address several 
technical questions related to Decree 248. However, important issues remain to be resolved.  
2.345.   The representative of The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu  
provided the f ollowing statement. Because there is no progress on this STC and the lack of 
transparency continues to be an issue, we would like to reiterate our concerns in the previous TBT 
meetings. Given the wide range of our food industries that have been or may have  been affected by 
this measure, the Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu has been 
closely following the implementation of the measure. Many concerns over the measure remain even 
after it took effect on 1 January 2022. First, the l ack of sufficient information about registration 
requirements, operational guidelines, and updates of the stages of the procedure is one of the 
biggest difficulties we face. This issue is even more critical for those facilities that need to file the 
applic ation by themselves. Without sufficient guidance, the facilities are unable to complete 
registration, and trade may be disrupted as a consequence. To avoid trade disruption, we urge China 
to designate an Enquiry Point that can provide effective and timely assistance for facilities to contact 
directly with concerns about the online registration system. Also, we urge China to hold an 
information session in the WTO for trade partners to learn more about the General Administration 
of Customs of China (GACC)'s i mplementation of the measure.  
2.346.   Second, there are also concerns over the measure's review and approval procedure. 
Standard or anticipated processing periods are unknown. So is the stage of the application. In 
addition, some of our facilities were rejected by  the GACC without further explanation, while others 
cannot correct their application in the registration system. Under Article 5.2.2 of the TBT Agreement, 
Members shall ensure that the standard processing period of each conformity assessment procedure 
is published to the applicant and, upon request, the applicant is informed of the stage of the 
procedure. We request that the GACC comply with the requirements set out under the TBT 
Agreement, including the transparency requirement and informing the applicant in a precise and 
complete manner of all deficiencies and allowing corrective actions. Third, other difficulties we face 
include the ambiguity of HS code categorization and the scope of the products subject to this 
measure. Some of our facilities reported t hat their products have faced customs clearance 
suspension for no reason. Ever since China made notification to the WTO in 2020, we have expressed 
our concerns and sought clarification from China several times through both bilateral channels and 
this forum ; however, we have yet to receive a sufficient and detailed response from China. We 
therefore once again urge China to offer sufficient and detailed guidelines and designate an Enquiry G/TBT/M/88  
 
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  Point. Also, as any measure of this magnitude requires far more time fo r industries to implement, 
we urge China to offer a longer grace period for implementation, so as to avoid serious trade 
disruption. We also suggest that China temporarily allow entry of all products from registered 
facilities. This additional time will al low facilities to accurately enter or update the product 
information in their online registration.  
2.347.   The representative of the United States  provided the following statement. The United States 
remains deeply concerned with this measure, published as Decree 2 48 on 12 April 2021, and 
implemented on 1 January 2022. We continue to question the food safety and public health benefits 
of China's burdensome facility and product registration requirements, and whether such benefits are 
based on science or risk. We rene w our repeated requests that China provide the scientific rationale 
and any risk assessment performed that would justify this measure. The United States notes that 
the lack of guidance provided by China and China's implementation and enforcement of the mea sures 
continues to cause considerable confusion for exporters and competent authorities. The changing 
application of these administrative measures is directly leading to disruptions in trade. US agencies 
continue to face administrative burdens as they work  to resolve issues with shipments held up at 
ports in China. The General Administration of Customs of China (GACC) should continue to use 
existing government -to-government facility registration processes already implemented under 
bilateral agreements, as e nvisioned in Article 11 of Decree 248, and not require facilities to provide 
additional information online. Furthermore, GACC requires foreign competent authorities to approve 
information and upload inspection reports to China's online system for each regi stered facility from 
their country producing certain categories of products. Such a requirement creates tremendous 
administrative burdens on foreign competent authorities without a clear connection to food safety 
outcomes. GACC should ensure that all facil ities not already registered under existing government 
to government facility registration processes are able to self -register without foreign competent 
authority involvement, thereby streamlining the process and facilitating trade.  
2.348.   China's failure to act in this area necessitates the United States to continue raising these 
concerns at the TBT Committee until our concerns have been addressed by GACC. We note that 
GACC's requests for additional detailed information from facilities and competent authorities, such 
as process -specific food safety plans and photographs on an establishment -by-establishment basis, 
as part of its pre -import registration requirements do not appear consistent with Codex guidance 
that allows for the recognition of an exporting country' s food control (see Codex Guidelines for Food 
Import Control Systems - CXG 47 -2003 – Paragraph 13). Furthermore, we ask that China hold an 
informational session in Geneva for trading partners to learn more about implementation of Decree 
248. We look forwar d to China's response to these specific questions and comments.  
2.349.   The representative of the Republic of Korea  provided the following statement. The 
administrative measures for registration of overseas manufacturer of imported foods 
(G/TBT/N/CHN/1522 ) The Republic of Korea echoes th e concerns raised by Canada, Kenya, 
Australia, Japan, the European Union, Chinese Taipei, and the United States under this Specific Trade 
Concern. Korea respects China's efforts to ensure consumer safety and appreciates its continued 
cooperation through bi lateral channels. However, Korea remains concerned since China's measures 
still includes low -risk food products provided in Article 7 of Decree 248, which is creating unnecessary 
obstacles to trade. While Korea is registering newly added product categories  in accordance with 
GACC's requirements, it is taking a significant amount of time for the registration to finalize. 
Moreover, facilities are rejected without explanation, leading to a negative impact on trade.  
2.350.   Korea also requests China allow companies of the product categories outlined in Article 7 
register their respective establishments on the GACC website themselves. The current requirements 
are resulting in inefficiency such as having to apply for each category the facilities wants to register 
and havi ng to submit duplicate data, as facilities are required to apply for registration based on 
product categories. If China adopts the measure suggested by Korea, China will be able to swiftly 
process registration applications. Moreover, Korea asks China to ut ilize previously reviewed data so 
that registered facilities could export all products of the facilities. Additionally, obligating facilities to 
register food products that are clearly labelled as a free sample that is not sold or consumed is a 
measure tha t hinders mutual growth of Korean and Chinese food industries. Many other countries 
do not apply such measures to sample products and Korea therefore requests China to ease related 
regulations. Korea would like to remind China that all WTO Members have the  obligation to 
implement food safety regulations based on sound scientific basis and transparency. As the new 
measures significantly affects bilateral trade, Korea would like to ask China to provide a response to 
our statement.  G/TBT/M/88  
 
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  2.351.   The representative of Brazil  provided the following statement. Brazil would like to support 
STC 611 regarding new requirements for the registration of overseas producers of imported foods. 
So far, both bilaterally and at the TBT Committee, the Chinese government has not been able to 
clarify the risk analysis that grounded such disproportionate requirements for a wide range of food 
products. We understand that these requirements constitute unnecessary obstacles not only to our 
private sector, but also to our regulators, which must oper ate as the Competent National Authority 
for a much wider range of products. Not only are the regulators facing an unreasonable increase in 
their burden, but some of them must also make recommendations on products or producers that 
are actually subject to i nspection by authorities of other levels of government. In April 2021, the 
General Administration of Customs of China (GACC) published Decrees no. 248 and 249, which deal, 
respectively, with administration of registration of foreign establishments and mana gement of the 
safety of imported and exported food. Article 5 of Decree no. 248 requires that the food safety 
management system of the country where the producer is located has passed GACC's equivalence 
assessment or review. Could China explain how and whe n it intends to carry out these assessments? 
Could China indicate the criteria and procedures used to establish such equivalence, especially for 
regulators of processed foods and "health foods "? 
2.352.   The representative of Switzerland  provided the following stat ement. Switzerland shares – 
and supports – concerns expressed by other Members regarding decrees 248 and 249 published by 
the General Administration of Customs of the People's Republic of China (GACC). Switzerland 
supports China's objective to ensure that only safe food and food from legitimate sources is 
imported. However, we regret to note the persisting problems and uncertainties with the CIFER 
system. Switzerland strongly encourages China to extend the June 2023 deadline for the renewals 
and the validit y of existing approvals of establishments falling under Art 7 of Decree 248 by one 
year. This additional time would enable GACC to fix the problems related to the CIFER system and 
allow our authorities as well as the establishments to accurately enter or u pdate product information 
in their online registration. Finally, we support other Members' call for the creation of contact points 
for industry and authorities. We look forward to China's response to these comments.  
2.353.   The representative of Mexico  provided the following statement. The delegation of Mexico 
reiterates its concern regarding Decree 248 notified on 16 November 2020 in document 
G/TBT/N/CHN/1522 , which entered into force on 1 January 2022. Mexico also shares the concerns 
raised earlie r by previous speakers. As mentioned at the July meeting, while efforts have begun to 
ensure that the registration of Mexican companies exporting to China is carried out in a satisfactory 
manner, we have identified that concerns remain about potential effe cts on international trade, since 
we have been made aware of recent issues in the process for the registration of Mexican companies. 
In this connection, we reiterate how important it is for the measures adopted by Members of this 
Committee to comply with t he international commitments contained in the TBT Agreement.  We also 
ask the delegation of China to provide a point of contact that may offer assistance to companies that 
have experienced difficulties in registering. We welcome and support the request mad e to China to 
hold briefings in Geneva on the implementation of its Decree 248. Lastly, the delegation of Mexico 
thanks the delegation of China for giving its consideration to this statement.  
2.354.   In response, the representative of China  provided the following statement. China has on 
multiple bilateral and multilateral occasions clarified why and how China sets to revise the regulation 
as instructed by relevant laws and given specific technical guidance to Members' enquiries. China 
thanks all the Members who hav e sent their inquiries and suggestions, which have helped us to 
smooth the registration process. China would like to ensure Members again that the revision has 
been done in an open and transparent way, compliant with common international rules and practice s. 
The implementation of the regulations has taken into account trade facilitation in addition to 
strengthening food safety. Before implementing the regulations, GACC issued interpretation of the 
regulations and guidance on registration, clarified supporti ng documents and forms for registration, 
launched the registration information system for overseas enterprises, and formally notified the 
members which export food to China through diplomatic channels and cooperation mechanisms. As 
of 27 October 2022, more  than 100 Members have provided their list of enterprises recommended 
for registration, with a total of 79,000 overseas producers successfully registered. So far, the 
implementation goes well. We understand some Members might still have confusion when 
registering. They are welcome to contact GACC at any time for timely technical support.  G/TBT/M/88  
 
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  2.1.4.37   Kingdom of Saudi Arabia - Saber Conformity Assessment Online Platform / 
Saleem Product Safety Program (ID 61571) 
2.355.   The representative of the European Union  provided the follo wing statement. The 
implementation of the electronic certification system SALEEM through the web -portal SABER remains 
a concern for the European Union. Several European industries coincide in reporting the difficulties 
they are facing and in particular the  overly costly, burdensome and time -consuming nature of the 
conformity assessment requirements. The sector of toys is particularly affected. European toy 
manufacturers continue to report difficulties related to obtaining a GCC Conformity Tracking Symbol 
(so-called GCTS) from notified bodies authorized by Saudi Standards, Metrology and Quality 
Organisation (SASO). The European Union refers to its previous statements delivered  respectively 
in November 2021 and March 2022. Following the constructive bilateral  talks we had during this 
week, the European Union is confident that remaining concerns will soon be addressed by the 
Kingdom of Saudi Arabia and will ensure efficient and less costly procedures for all products included 
in the new conformity assessment sy stem.  
2.356.   The representative of Switzerland  provided the following statement. Switzerland would like 
to support the concerns on the "Saber Conformity Assessment Online Platform ". We remain 
concerned over the negative impact on bilateral trade with the Kingdom  of Saudi Arabia and refer 
to our previous statements in the WTO TBT Committee. The registration and certification process 
seems to remain non -transparent, complex and time -consuming for our exporters. The industry 
continues to report that the conformity a ssessment procedures lead to disproportionate fees and in 
many cases to unnecessary administrative burden, costs and duplicative requirements. In particular 
for companies exporting quality products in small quantities, this additional burden is prohibitive  to 
enter the market. Switzerland would appreciate if the Kingdom of Saudi Arabia could ensure that 
the registration and certification process is not more strict than necessary to give adequate 
confidence that products fulfil the applicable requirements. F urthermore, we encourage the Kingdom 
of Saudi Arabia to base the documentation and certification requirements on international standards 
and practices and to ensure that the requirements are applied in an equal and uniform manner.  
2.357.   The representative of Canada provided the following statement. As stated in previous TBT 
Committee meetings, Canada supports Saudi Arabia's efforts to create an integrated system that 
efficiently assesses the safety of imported products. In a recent communication with us, stakehol ders 
indicated that they have observed some positive movement by the Saudi Standards, Metrology and 
Quality Organization (SASO), which has acknowledged that the Notified Bodies should be more 
consistent in administering the conformity assessment procedures . Canada welcomes such progress. 
However, industry stakeholders continue to be concerned with the implementation requirements 
established by Notified Bodies, which continue to pose unnecessary administrative burden, costs and 
duplicative requirements for t hem. Canada would kindly ask that Saudi Arabia's SASO play a more 
active role to monitor the notified bodies closely and to ensure that they are consistent and 
transparent in administering the conformity assessment procedures. Finally, Canada kindly asks 
Saudi Arabia's consideration of providing more detailed guidance to Notified Bodies on how to 
implement the SABER platform in order to increase the efficiency of the system, reduce compliance 
costs and ensure consistency.  
2.358.   In response, the representative of the Kingdom of Saudi Arabia  provided the following 
statement. "Saber" is an IT Platform that aims to improve the import experience by easing the 
conformity process/procedure before the shipment arrival. In addition, all Technical Regulations 
reflected in " Saber" are notified in the WTO through (TBT E -Ping Platform). Furthermore, "Saber" 
has contributed to facilitating and enhancing trade, reducing the cost and time of custom clearance 
to one to seven working days compared to 7 -15 working days in previous ye ars. As a result, the 
Kingdom's ranking in the cross -border trade index advanced 72 ranks, confirming SASO's 
commitment to boosting trade facilitation. The Gulf Standardization Organization accepted many 
notified bodies worldwide to facilitate the applicat ion of the children's toys regulation requirements. 
On the other hand, the E -platform "SABER" does not require additional certificates of conformity as 
long as the GSO certificate of conformity is valid. Therefore, processing shipment certificates through 
the "Saber " platform would be fast and easy. We would also like to point out that, the validity of the 
GSO conformity certificates lasts for three years, and then the conformity procedure is considered 
fair. Concerning toys for individuals over 14 years ol d, which are excluded from the scope of the 
Gulf regulation, the Supplier Conformity Declaration through "SABER" only is sufficient. In 
 
71 For previous statements follow the thread under ID 615 . G/TBT/M/88  
 
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  conclusion, Saudi Arabia is always happy to collaborate and engage with all interested countries and 
stakeholders, in or der to address related issues bilaterally.  
2.1.4.38   Colombia - Food Prioritized for its Sodium Content, Certification Requirements, 
G/TBT/N/COL/238 , G/TBT/N/COL/238/Add.1  (ID 60972) 
2.359.   The representative of Costa Rica  provided the following statement. First of all, Costa Rica 
would like to express its appreciation for the efforts of the Colombian authorities to provide 
information related to its regulation on the maximum sodium c ontent for a prioritized list of foods. 
In this regard, we note that we have received information on the reasons and justification for this 
Colombian regulation. Nevertheless, Costa Rica would like to reiterate its request that Colombia 
share with us eithe r the Codex Standard setting out the percentages for the maximum sodium 
content per food, or the risk analysis performed in order to determine these percentages. As is the 
case with front -of-pack nutritional labelling, there are no international reference standards that form 
the basis for  setting percentages for the maximum sodium, fat or sugar content, above which a 
specific product cannot be sold in a particular market (as is the case with the list of foods prioritized 
by Colombia and the maximum sodium percentages) or a stop sign or a black label must be placed 
on the package in order to discourage people from consuming the product. As a result, there are 
different regulatory systems for the international trade in processed foods, which makes sectors les s 
competitive and restricts trade more than necessary.  
2.360.   The representative of Paraguay  provided the following statement. Paraguay recognizes and 
supports the right of Colombia to protect the health of its population by limiting the sodium content 
of some fo ods as part of efforts to protect against chronic non -communicable diseases. However, 
Paraguay is concerned that the provision of lot -by-lot certificates of conformity would be burdensome 
for importers and more restrictive than necessary to achieve the leg itimate objective pursued by 
Colombia with this measure.  
2.361.   The representative of Guatemala  provided the following statement. Guatemala wishes to 
thank Costa Rica for including this item on the agenda. We reiterate the recognition of the legitimate 
objective of the Colombian Government to ensure human health, and the efforts made to lower total 
sodium intake in Colombia in order to reduce hypertension and other related diseases. Resolution 
No. 2013 of 2020, by which the technical regulation that establishes th e maximum sodium content 
for processed foods prioritized under the National Strategy for the Reduction of Sodium Consumption 
and other provisions are issued, provides, in chapter III, that a certificate of conformity to 
demonstrate compliance with the requ irements contained in the regulation, must be obtained and 
attached to the import licence or registration, as the case may be, at the time of its presentation at 
the Single Window for Foreign Trade (VUCE). Likewise, it is proposed that once the country has  its 
first accredited certifying entity, the declaration of conformity issued by the manufacturer will 
accepted, which will be valid for up to 24 months, after which time only certifications issued by the 
bodies recognized in the regulation will be accepte d. Due to the fact that this certificate of conformity 
must be submitted for each import, Colombia is asked about the actions to be taken if the 
manufacturing company consistently demonstrates regulatory compliance and the possibility of 
continuing to subm it first -party certificates of conformity. Guatemala reiterates its concern with 
sodium intake , and reiterates statements made in previous Committee meetings.  
2.362.   In response, the representative of Colombia  provided the following statement. On this 
matter, Co lombia would like to point out that Resolution No. 2013 of 2020 reflects public health 
policy and is part of a comprehensive strategy that considers both the sodium content of processed 
foods and other sources of added salt. The strategy seeks to reduce mo rtality attributable to high 
blood pressure and cardiovascular disease by gradually reducing salt intake from food sources until 
the WHO recommendation for 2021 has been achieved: 5 grams of salt or 2 grams of sodium per 
person per day. On previous occasio ns, Colombia has shared documents justifying the measure 
taken through the aforementioned Resolution on the maximum sodium content in processed foods. 
Colombia would like to reiterate that our authorities are stand ready to pursue technical discussions 
with the authorities of the interested countries, in order to clarify the concerns raised around trying 
to comply with the technical regulations on the maximum sodium content in processed foods. 
Notwithstanding the foregoing, we would appreciate it greatly if  Costa Rica could clarify its concern, 
as it makes reference to Resolution No. 2013 of 2020, which contains the technical regulation on 
maximum sodium content notified in document G/TBT/COL/238 . However, in its arguments and 
 
72 For previous statements follow the thread under  ID 609 . G/TBT/M/88  
 
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  when addressing the issue, Costa Rica refers to a different m atter, in particular, the technical 
regulation contained in Resolution No. 810 of 2021 on nutrition and front -of-pack labelling, notified 
in document G/TBT/N/COL/246 . In this connection, we reiterate our willingness to keep the matter 
on the agenda of the relevant authorities, so t hat we can provide elements which will make it easier 
to understand the standards and comply with them. We would also like to invite the delegation of 
Guatemala to send their concerns to us in writing, so that the relevant internal consultations could 
be undertaken . 
2.1.4.39   Mexico - Draft Amendment to Mexican Official Standard NOM -051-SCFI/SSA1 -
2010: General specifications for the labelling of pre -packed food and non -alcoholic 
beverages, G/TBT/N/MEX/178/Add.9  (ID 60873) 
2.363.   The representative of Costa Rica  provided the following sta tement. Costa Rica would like to 
take this opportunity to emphasize the importance of harmonizing food labelling schemes, in 
particular front -of-pack nutrition labelling, on the basis of Codex regulations (Guidelines on Nutrition 
Labelling CXG -2-1985, Anne x 2, adopted in 2021). In this regard, we encourage the use of the 
recently approved Codex guidance on the subject as a reference to ensure that regulations are 
consistent with the international consensus and do not establish unnecessary restrictions on tr ade. 
Costa Rica defends the importance of the work done in the framework of the Codex Alimentarius 
and argues for the need for the adopted food -labelling measures to be based on scientific evidence 
and on Codex Standards, as set out in the Agreement on Tec hnical Barriers to Trade. To date, the 
Codex Alimentarius has not determined percentages of sodium, fat or sugar content, above which 
consumers must be warned through labels with stop signs or black stamps which are designed to 
discourage people from consu ming the product. This lack of harmonization and scientific evidence 
has resulted in the proliferation of various front -of-pack food labelling schemes, with different 
content -percentage thresholds at which a warning is required, all of which increases the costs 
associated with international trade in food, makes businesses less competitive and ultimately 
introduces unnecessary obstacles to trade.  
2.364.   The representative of Paraguay  provided the following statement. Paraguay supports 
Mexico's goal of protecting pu blic health and considers that the provision of nutritional information 
to consumers is an appropriate strategy. However, Paraguay expresses its concern over its 
enforcement since there is no analytical method for distinguishing total sugars from added sug ars 
in food. Therefore, we would ask Mexico if this would not render enforcement difficult.  
2.365.   In response, the representative of Mexico  provided the following statement. As has been 
previously mentioned by Mexico, we are aware that international schemes for the labelling of foods 
exist under Annex 2 to the Codex Alimentarius Guidelines on Nutrition Labelling (CXG 2 -1985), 
adopted in 2021. We should reiterate, however, that at the time NOM -051 was being prepared, there 
were no international reference standards  that could be used as a basis for establishing front -of-
pack labelling. The adoption, modification and/or annulment of technical regulations in Mexico are 
governed by the standardization process, time frames and stages established under the Law on 
Quality  Infrastructure. The Government of Mexico reiterates its undertaking to comply with the 
international commitments set out in the Agreement on Technical Barriers to Trade and in the free 
trade agreements to which Mexico is party, while also recognizing the legitimate public policy 
objective of safeguarding the Mexican population's health generally.  
2.1.4.40   European Union - Draft Commission Regulation laying down eco -design 
requirements for electronic displays pursuant to Directive 2009/125/EC of the European 
Parliam ent and of the Council, amending Commission Regulation (EC) No 1275/2008 and 
repealing Commission Regulation (EC) 642/2009 (and its accompanying annexes)", 
G/TBT/N/EU/609 , G/TBT/N/EU/610  (ID 57574) 
2.366.   The representative of the Republic of Korea  provided the following statement. The Republic 
of Korea respects the efforts of the European Parliament and the Council to protect the environment. 
Furthermore, Korean companies are endeavouring to comply with the EU 's Ecodesign Requirements 
for Electronic Displays (hereinafter, the Regulation). Regarding the 8K displays, Korea has 
recognized the EU's position indicated in the written response on 14 July to our written comments 
communicated via the TBT Enquiry Points,  as well as the EU's response statement provided at the 
 
73 For previous statements follow the thread under ID 608 . 
74 For previous stat ements follow the thread under ID 575 . G/TBT/M/88  
 
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  last July 2022 WTO TBT Committee meeting. However, it is deeply concerned that enforcement of 
the Regulation's Tier 2 on 1 March 2023 as scheduled will cause serious damage to the 8K display -
related i ndustry and market along with the problem of applying excessive criteria that were 
established without taking into account the current technological development and relevant empirical 
data. Korea would like to reiterate the following comments. First, it is  technically excessive and 
unreasonable to apply the same efficiency requirement to the "8K displays" (hereafter, 8Ks) as that 
on the "4K displays" (hereafter, 4Ks). 8Ks feature four times more pixels compared to 4Ks, and 
since each pixel needs to be power ed, 8Ks require four times more energy than 4Ks typically. 
Therefore, for 8Ks, it will be technically reasonable to apply a more relaxed energy efficiency criteria, 
rather than the same one that is applied to 4Ks.  
2.367.   Second, the period when the EU reviewed th e power consumption data of electronic display 
products on the market to prepare the current Regulation's requirements was even before the 8Ks 
were first launched in the EU market around the end of 2018. Consequently, it is concerned that the 
data on 8K pr oducts' power consumption level, which is about four times higher than that of 4Ks, 
were not duly taken into account at the establishment of the criteria. Hence, it is necessary to review 
the power consumption data for 8Ks and "Micro LED displays" (hereaft er, Micro LEDs) appropriately. 
Third, if the sales of 8Ks and Micro LEDs get restricted by the enforcement of the excessive Tier 2 
criteria, EU consumers would lose the opportunity to use those products, and their right to choose 
would be infringed. The ab sence of 8K products in the market, should it transpire, might also work 
unfavourably towards the consumers, as a price -increasing factor for the existing 4Ks. Furthermore, 
such impacts may be extended to the emerging 8K broadcasting and content industry b ecause the 
demand for 8K contents will drop sharply in the EU region. Therefore, Korea would like to request 
that the EU collect the power consumption data for 8Ks and Micro LEDs and review the Regulation 
until 25 December 2022, as specified in Article 8 o f the Regulation and section 7 of the Ecodesign 
and Energy Labelling Working Plan. In the event that it is difficult to conduct the Review by this date 
due to the current geopolitical situation, Korea requests that the EU postpone the enforcement date 
of Tier 2 until the Review is completed.  
2.368.   In response, the representative of the European Union  provided the following statement. 
Thank you Chair and thanks to Korea for raising this issue. As already indicated in July, this measure 
was notified to the WTO on 9  October 2018 and allowed for 60 days of comments. The energy 
efficiency requirements for electronic displays have been known since 2019 and are applicable since 
March 2021, except for displays with very high resolutions, which benefit from a specific, tem porary 
exemption until 1 March 2023. A review of this adopted regulation is not among the priorities 
identified in the Ecodesign and Energy Labelling Working Plan adopted on 30 March 2022, given the 
geopolitical situation and the acute energy crisis in Eur ope. While we understand that very high -
resolution displays have some technological constrains affecting, to a certain extent, their power 
consumption, the EPREL data submitted by manufacturers under their energy labelling obligations 
does not confirm that , currently available, 8K displays consume four times more energy than 
comparable 4K models.  
2.369.   Recent technical discussions between the European Commission and a Korean display 
manufacturer confirmed the existence of three yet unexploited low -cost technical options to lower 
consumption (including addressing a decisive "out -of-the-box" default brightness setting) and a 
clearer, shared understanding of the current rules. As a consequence, the manufacturer confirmed 
to the Commission that it will be able to cont inue placing, at least some, 8K TVs on the EU market 
after 1 March 2023. From its side, the European Commission will begin a review of the rules in 2023, 
but given the overall need to increase energy efficiency, also in the medium - and long -term to reach 
our climate goals, it cannot be taken for granted that the review would lead to laxer requirements – 
quite the opposite. Postponing the Tier 2 ecodesign application date would above all circumvent the 
EU consultation and decision -making process involving al l stakeholders and EU member States. It 
would be also unfair towards other manufacturers that might have refrained from marketing such 
products in view of the requirements applicable as of March 2023. Last but not least, a weakening 
of the ecodesign requir ements is not coherent with the current EU's energy policy objectives. These 
days, weeks and months, unprecedented measures are being put in place to urgently reduce 
electricity demand across the Union to minimize the extraordinary hardship already felt by  most 
citizens, SMEs and businesses.  G/TBT/M/88  
 
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  2.1.4.41   European Union - Non-renewal of the approval of the active substance 
mancozeb, G/TBT/N/EU/712  (ID 62775) 
2.370.   The representative of Paraguay  provided the following statement. This concern and the 
non-renewal of the approval of other substances were already discussed extensively both in this 
Committee and in the SPS Committee because of the subsequent reduction in the MRLs. Paraguay 
therefore refers to its previous statements and reiterates its cross -cutting concern with regard to 
the EU's decision not to renew the approval of these substances without a proper risk analysis and 
without complying with scientific principles.  The arguments in favour of the use of this substance 
have not changed either, and these are shared by the EU, or at  least by several of its members, who 
consider them sufficient to provide emergency authorizations:  the lack of available alternatives to 
protect against some pests,  the importance of mancozeb to avoid problems with resistance and, in 
general,  the producti on and financial losses caused by some pests that only this substance can 
combat effectively.  We have already heard the EU say that the measures are only in place for 120 
days, but we recall that there is no limit to the number of times that they can be re newed.  We see 
for example how many of the emergency authorizations for mancozeb are given for approximately 
the same annual period, probably linked to the threshold of humidity and warm temperatures that 
increase the prevalence of some of the fungi that ar e effectively and safely controlled by substances 
like mancozeb.  
2.371.   Imagine  how much more often these thresholds are reached in subtropical countries like 
Paraguay with climatic conditions very different from those of the European Union.  We also heard 
the EU explain that emergency authorizations are not intended to facilitate trade, unlike import 
tolerances, but we have not received answers to repeated written questions on the specific 
mechanisms used to grant emergency authorizations and to ensure that produc ts with temporary 
MRLs are kept within the borders of the authorizing Member, and on the consistency between these 
authorizations and alleged concerns about the use of these substances, in relation to which we note 
not only the discrimination that exists i n practice between EU producers and trading partners but 
also an inconsistency between the legitimate objective pursued and the actions taken to achieve it.  
Lastly, we have also heard that, although emergency authorizations are granted by EU members, 
the E FSA reviews them in case it considers that they are not properly justified. However, we note 
that even in cases where the EFSA considers that an emergency authorization is not properly 
justified, there are no restrictions on new emergency authorizations, w hich continue to be approved 
by the same members for the control of the same pests on the same crops for which the EFSA 
concluded that it was not properly justified.  
2.372.   Paraguay shares the objectives that the EU seeks to meet with these policies but does not 
share its adopted method for attaining them because it is not based on conclusive scientific evidence 
and does not consider less trade -restrictive options or valid alternatives for hazard control, which do 
not exist in this case, as the EU agrees by granti ng emergency authorizations to its members.  We 
reiterate our question on how the Members concerned by the process can participate in the analysis 
that the EFSA is conducting on the MRLs for mancozeb; on the current status of the analysis, since 
an outcome was expected in the first half of 2022; and on how comments submitted by Members 
will be taken into account.  We are also seeking detailed responses to the queries regarding 
emergency authorizations that were raised in the SPS Committee and were not satisfa ctorily 
answered with the statement that it "is the responsibility of the EU member States". We recall that 
EU members are also members of the WTO in their own right, so perhaps we should address 
questions to each of them if we continue to receive no respo nse. Lastly, Chair, we cannot fail to 
recognize the extraordinary efforts that the EU is making in the bilateral/plurilateral and multilateral 
spheres, including through dual notifications (TBT/SPS). However, what my country and my 
country's producers need  is not a unilateral explanation of the measures but a frank dialogue that 
allows the legitimate demands we are making to be met while at the same time achieving the EU's 
legitimate objectives in the least trade -restrictive way possible, in compliance with  the rules and 
principles of the multilateral trading system.  
2.373.   The representative of Brazil  provided the following statement. Brazil would like to convey 
once again its concerns regarding the non -renewal of the approval of the active substance mancozeb, 
according to European TBT notification 712. Mancozeb is a substance whose use is approved for 
many different crops by the Brazilian Health Regulatory Agency, including soy. MRLs for soybeans 
in Brazil are set in 0,3 mg/kg. Around 11% of the soy produced in Br azil is exported to the EU. 
 
75 For previous statements follow the thread under ID 627 . G/TBT/M/88  
 
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  Therefore, restrictions on mancozeb will significantly impact the income of Brazilian farmers. The 
availability of an alternative to mancozeb in the short to medium term is also limited by the fact that 
other substances of simil ar use have already been banned in the European market, such as 
chlorothalonil. Mancozeb is an important substance for the management of fungicide resistance to 
control soybean rust. It is used as a crop protection additive, intended to increase the effect iveness 
of other fungicides, minimizing resistance, and prolonging the life cycle of other molecules. In light 
of the insufficient transitional period granted by the EU, such crops could not have their treatments 
changed in time for exportation to the EU m arket before the entry into force of the regulation. Brazil 
would like to urge European authorities to consider establishing transition periods that are adequate 
to the production cycle of the affected crops. Brazil also respectfully asks the EU to align M RLs with 
limits established under the framework of Codex Alimentarius, to consider less trade -restrictive 
alternatives that would also safeguard its legitimate policy objective and to grant a treatment for 
Brazilian farmers no less favourable than that gra nted to European farmers.  
2.374.   The representative of Colombia  provided the following statement. Colombia reiterates its 
concern about the measure notified by the European Union relating to the non -renewal of the 
approval of the active substance mancozeb. As we have already noted, the European Union has 
adopted measures resulting in the non -approval of the use of certain products, which is affecting 
international trade, in particular exports from Colombia. Measures to suspend or not approve the 
marketing of vario us active substances and the subsequent reduction of their maximum residue 
levels (MRLs) to the lowest limit of detection, are being taken without any sound scientific evidence 
and without demonstrating that they are indeed the least trade -restrictive meas ures to achieve the 
desired level of protection. As we have already referred to the importance of this plant protection 
substance at previous meetings, on this occasion, we would like to ask the European Union to provide 
clarification about the relationshi p between the notification in document G/TBT/N/EU/712 , on 
mancozeb, and the notification in document G/TBT/N/EU/797  regarding the REACH regulation and 
substances that are carcinogenic, mutagenic and toxic for reproduction.  
2.375.   We recall that Article 2.12 of the TBT Agreement provides for a reasonable interval betwe en 
the publication of technical regulations and their entry into force in order to allow time for producers 
in exporting Members, and particularly in developing country Members, to adapt their products or 
methods of production to the requirements of the im porting Member. In line with the above, we 
understand that the MRLs for mancozeb are covered by the MRLs for the dithiocarbamate chemical 
family, which the European Union has begun to review. In this regard, and taking into account that 
the procedure curre ntly being followed by the European Food Safety Authority (EFSA) is different 
from the international public consultation process that should be followed under the TBT Agreement, 
we urge the European Union to notify the relevant standards at an early stage and to take Members' 
comments into account. The foregoing, with the sole aim of guiding actions towards good regulatory 
practices, under which standards must be based on clear and objective information, and which 
promote open dialogue with stakeholders, tr ansparency and the minimizing of market distortions.  
2.376.   The representative of Australia  provided the following statement. Australia recognizes the 
European Union's (EU) right to regulate the manufacture and use of plant protection products in 
agriculture to a ddress risks unique to its jurisdiction. However, Australia reiterates its concerns 
raised at previous TBT Committee meetings about the EU's proposed non -renewal of mancozeb and 
the potential impact on maximum residues limits (MRLs) and effects this may ha ve on trade, 
including wine exports to the EU. Australia welcomes information on the European Food Safety 
Authority's scientific opinion on the concerns we have previously outlined. We note our competent 
domestic authority – the Australian Pesticides and V eterinary Medicines Authority – and Codex have 
determined MRLs for dithiocarbamates that ensure the continued protection of human, animal and 
environmental health while allowing trade to continue.  
2.377.   The representative of Kenya  provided the following statemen t. Kenya wishes to join the rest 
of the delegations in raising concerns towards EU's proposal for non -renewal of the approval of the 
active substance mancozeb. The active substance mancozeb is an important molecule in pest control 
in Kenya. Mancozeb -contai ning products are used in the agriculture sector for the control of a wide 
range of fungal diseases found in the tropics. Its use is critical in the flower industry, which is a 
leading sector in terms of the Kenya 's GDP and also employing thousands of Kenyans thus impacting 
livelihoods.  Mancozeb has been an important molecule in relation to fungal pathogens control on a 
number of vegetable crops including potato, tomato, onions , among others.  There are no available 
alternatives to offer multisite fungicide for control of early and late blight on the above crops; which 
cause annual yield losses of up to 60 -70% on the 4.5 -5.5 million metric tonnes (USD 1.9 billion) of G/TBT/M/88  
 
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  potato, 560,000 metric tonnes (USD 333 million) of tomato respectively produced in Kenya for local 
consumption.   
2.378.   Potato is the second  largest consumed produce in Kenyan households after maize.  Mancozeb 
has a multi -site contact activity which is a key aspect for resistance management.  Kenya wishes to 
raise this STC since the measure is deemed to be more trade restrictive than necessary contrary to 
Article 2.2 of the TBT Agreement.  Kenya notes that the EU has allowed for emergency use of this 
active substance to some of its members, owing to lack of alternati ves. This is inconsistent with the 
non-discrimination principle of the WTO and the provisions of Articles 2 and 5 of the TBT 
Agreement.  Kenya requests the European Union to consider the withdrawal of the Regulation as the 
measure is more trade restrictive than necessary . 
2.379.   The representative of Ecuador  provided the following statement. Ecuador reiterates its 
concern over the non -renewal of mancozeb. As we have already mentioned on previous occasions, 
this fungicide is used for many strategic crops produced in  Ecuador and the region, including bananas 
and cocoa, among others.  The importance of this plant protection substance has already been 
mentioned on previous occasions. Therefore, Ecuador is concerned that there are currently no 
approved alternatives to mancozeb that are duly registered and equally effective as mancozeb.  The 
case of mancozeb is of particular importance not only for bananas, but also for other lesser export 
crops. Recent research by international bodies, which has been presented to the EU rap porteur 
states, shows that mancozeb does not produce adverse effects in humans, experimental animals or 
wildlife at concentrations below those at which effects would be expected as a result of systemic 
toxicity.  In view of the above, it should be noted tha t, due to the way in which this substance is 
applied in banana production, the use of mancozeb is one of the most effective and environmentally 
friendly methods of phytosanitary control of black sigatoka, considering that this disease is the most 
destructi ve and poses the greatest economic risk to banana and plantain crops, with the potential 
to cause yield losses of up to 50%.  Therefore, prohibiting the use of this molecule —without effective 
alternatives — could have a very significant impact on the econom y of small -, medium -, and large -
scale producers in Ecuador.  Ecuador calls on the Europ ean Union to consider alternative measures 
that are less restrictive to trade, to identify substitute substances that enable  existing trade to 
continue , to base its measu res on conclusive studies , not only on the precaution ary principle , and 
to establish transitional periods of at least 36 months for the registration of alternative substances, 
in view of  the current  shortage of tools available to  control pest s.  
2.380.   The representative of Uruguay  provided the following statement. Mancozeb is an active 
substance that is authorized a nd widely used in many countries, such as Uruguay, where it is used 
safely to control diseases and pests in various products in the domestic  fruit and vegetable sector, 
such as apples, pears and citrus fruits. Of particular note is its use to control apple scab and pear 
scab, which are the m ain diseases affecting apple and pear production and are caused by fungi of 
the genus  Venturia spp . In that connection, we s hare the concerns and requests expressed by other 
delegations, particularly in view of the possibility that, as a result of the ongoing dithiocarbamate  
review process, the EU will significantly reduce the corresponding MRLs, even loweri ng them to the 
limit of determination, without having any conclusive scientific evidence that substantiates such a 
decision in line with the SPS Agreement of the WTO. We would appreciate an update on the status 
of the ongoing review process for these subst ances, including the predicted end date and the reasons 
for the apparent delay, as well as the date when a notification of any modification of the MRLs may 
be submitted to the SPS Committee. In that context, like o ther Members, Uruguay recalls the 
importan ce of taking due account of international standards, guidelines and recommendations, and 
the scientific information produced by international standard -setting bodies recognized by the WTO, 
such as the Codex Alimentarius , as well as the value of providing r easonable transition periods in 
the event that MRL modifications are finally determined  
2.381.   The representative of Costa Rica  provided the following statement. Costa Rica wishes to 
express its support for the concern raised by Paraguay, Brazil, Australia and Co lombia in relation to 
the draft implementing regulation notified by the European Union, under which approval for the use 
of mancozeb would not be renewed. We support the statements of the delegations that have joined 
the proponents of this concern.  
2.382.   The rep resentative of Chile provided the following statement. The delegation of Chile 
welcomes the previous statements on the non -renewal of the approval of the active substance 
mancozeb by the European Union and reiterates the trade concern expressed in this and  previous 
meetings of the TBT Committee.  G/TBT/M/88  
 
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  2.383.   The representative  of Panama  provided the following statement. In the interests of time, we 
would like to draw attention to our previous comments on this issue.  We urge the European Union 
to reconsider this measure and avoid unnecessarily restricting trade. We also request that the 
European Union offer a reasonable timeframe that respects the cycles of the agricultural sectors that 
would be affected by the imposition of the new MRLs.  
2.384.   The representative of Guatemala  provided the following statement. Guatemala maintains its 
position on the concern regarding the non -renewal of the approval of the active substance mancozeb, 
because there is no information that scientifically demonstrates the damage the active substance 
mancozeb could cause to human health. The European Union has mentioned on previous occasions 
that it has identified potentially negative effects for human health, without bringing scientific 
evidence to the discussion table. The European Union has notified t he Committee on Technical 
Barriers to Trade of the non -renewal of the approval of the active substance mancozeb. This will 
lead to a subsequent revision of the current permitted maximum residue levels, which will have a 
direct impact on agricultural export s to the European Union from countries with tropical climates. 
Mancozeb is key for the production of a number of strategic agricultural crops that are exported to 
the European Union, such as fruit (including bananas and plantains) and vegetables, which wou ld 
also affect other Latin American countries. In the light of the above, we request the European Union 
not to change the current maximum residue levels for mancozeb so as to avoid affecting the 
production and exports of Guatemala and other Latin American countries.  
2.385.   The representative of Argentina  provided the following statement. Argentina continued to 
share the general concern over the hazard -based approach used by the EU as regards regulating 
pesticides, without identification of risk, which is an unnece ssary technical barrier to trade. In the 
case of mancozeb, this is a broad -spectrum fungicide used for growing fruits, vegetables and 
extensive crops. Although Argentina shares the EU’s concern over strengthening the protection of 
human health and the envi ronment, we would once again like to underline the importance of 
complying with Articles  2.2 and 2.4 of the TBT Agreement to ensure that the technical regulations 
are not more trade -restrictive than necessary to fulfil a legitimate objective. We are partic ularly 
concerned by the number of substances banned by the EU Commission, which has been increasing 
with each passing day. This situation may have serious consequences for various WTO Members, 
particularly developing countries, whose populations and econom ies are highly dependent on 
agricultural exports. It is therefore crucial for the EU to use a risk assessment approach in the 
analysis of these regulatory changes and to have conclusive scientific studies to determine the 
various aspects that may affect hu man health and the environment.  
2.386.   In response, the representative of the European Union  provided the following statement. 
The European Union thanks WTO Members for raising this issue. We have provided detailed 
explanations on this issue in previous TBT Commi ttees. On 17 April 2020, the European Union 
notified, to the TBT Committee, a draft Commission Implementing Regulation concerning the non -
renewal of the approval of the active substance mancozeb, in accordance with Regulation (EC) No 
1107/2009 on the placi ng of plant protection products on the market (the "EU Plant Protection 
Products Regulation ").76 The Implementing Regulation (EU) No 2087/202077 entered into force on 
the 4 January 2021. The non -renewal was based on a scientific assessment conducted under the EU 
Plant Protection Products Regulation by experts from the EU member States and the European Food 
Safety Authority (EFSA). Since EFSA concl uded that mancozeb does not meet the approval criteria 
as outlined in Article 4 of Regulation (EC) No 1107/2009, the approval of this substance was not 
renewed.  
2.387.   EU member States had to withdraw existing authorisations for plant protection products 
containi ng mancozeb at the latest six months from the date of entry into force of the Implementing 
Regulation (by 4 July 2021). Possible grace periods granted by EU member States, in line with 
Article  46 of Regulation 1107/2009, expired, at the latest, on 4 Januar y 2022, 12 months after its 
entry into force. The EU would like to inform Members that EFSA has started a review of the existing 
 
76 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 
concerning the placing of plant protection products on the market and repealing Council Directives79/117/EEC 
and 91/414/EEC. OJ L 309 24.11.2009, p. 1. 
77 Commission Implementing Regulation (EU) 2020/2087 of 14 December 2020 concerning the non -
renewal of the approval of the active substance mancozeb, in accordance with Regulation (EC) No 1107/2009 
of the European Parliament and of the Council concerning  the placing of plant protection products on the 
market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011, OJ L 423, 
15.12.2020, p. 50.  G/TBT/M/88  
 
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  Maximum Residue Levels (MRLs) for dithiocarbamates (a group of substances of which mancozeb is 
part). We informed Members at th e last TBT Committee meeting that interested parties had been 
invited to actively contribute with relevant information to this MRL review through the main 
authorization holder, as described in document G/SPS/GEN/1494/Rev.1 .78 The EFSA scientific 
opinion on dithiocarbamate s is expected to be published in the second half of 2022. For advice on 
alternatives to mancozeb, the EU pesticides database79 is publicly available and contains information 
on all active substances, their approval status and their main purpose (e.g. fungi cide, insecticide or 
herbicide). Independently of the situation under the EU Plant Protection Products Regulation, use 
restrictions of mancozeb have been introduced under the EU Chemicals legislation (REACH80), 
following the classification of the substance  as CMR (carcinogenic, mutagenic or reproductive 
toxicant) 1A or 1B under that same Regulation.  
2.1.4.42   India – Toys (Quality Control) Order, 2020 (IND/131); Amendment in Policy 
Condition No. 2(iii) to Chapter 95 of ITC (HS), 2017 - Schedule -I (Import Policy) 
(IND/ 143), G/TBT/N/IND/68 , G/TBT/N/IND/131 , G/TBT/N/IND/143  (ID 63281) 
2.388.   The representative of the United States  provided the following statement. In the last five 
WTO TBT Committee meetings, the United States has urged India to provide a means by which US 
companies can resume shipments of toys to India. We note the inability t o secure factory inspections 
required by a Quality Control Order (QCO) is not unique to the toy industry. Other Members report 
that companies in industries including chemicals, paper, and automotive face the same barrier 
shipping goods to India. The last s hipment of toys to India by a US company was more than two 
years ago and if inspections of toy factories do not begin immediately, US companies are unlikely to 
ship any toys to India in 2022. Unfortunately, in July, during his monthly "Mann ki Baat " radio 
address, Prime Minister Modi celebrated the fact that imports of toys have fallen substantively in the 
last two years. In light of repeated confirmations from India that toy products produced by US -based 
entities are not the source of safety concerns, we u rge India to consider means by which US 
companies can comply with the QCO without further delaying US companies' exports of toys to India.  
2.389.   The representative of the European Union  provided the following statement. The increasing 
number of Quality Control O rders (QCOs) across sectors is sending worrying signals to EU industry, 
EU investors, and EU member States as the majority of QCOs introduced by India appear to have 
protectionist orientation and raise question in relation to their compliance with the WTO' s TBT 
Agreement obligations. The EU is deeply concerned by the fact that QCOs usually prescribe Indian 
specific standards where international standards already exist. Furthermore, they make mandatory 
conformity assessment procedures that are more restricti ve than necessary to fulfil their legitimate 
objective. The QCOs, in many cases require on -site audit at manufacturers' premises by an auditor 
of the Bureau of Indian Standards (BIS) for products manufactured in third countries to receive the 
approval/lice nce for exports to India. In view of the huge backlog of applications following COVID -19 
pandemic, the audit exercise is still slow and often results in delays in issuance of licences, which 
has economic impact on trade, as goods cannot be placed in the In dian market without the ISI mark.  
2.390.   The QCOs cause extra burden and economic cost to the EU industry that has to undergo 
cumbersome procedures, including obligatory testing in Indian laboratories, to obtain necessary 
permissions and/or licences for products already tested and certified under established international 
standards. Furthermore, the foreign manufacturers have to make necessary modifications in their 
tooling systems to incorporate the ISI mark. This causes temporary shutdown of production lines to 
make necessary changes and results in disruption of plant activities as well as in the financial loss 
for the plants during the period of closure. In this context, the QCOs add little value for Indian 
consumers, making the reason of their introduction not evident. As stated in previous TBT 
Committees, the European Union is concerned about India's Toys Quality Control Order (QCO) 
(G/TBT/N/IND/131 ) and the certification requirements introduced by the Bureau of Indian Standards 
 
78 
https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/G/SPS/GEN1494R1.pdf&Open=True   
79 https://ec.europa.EU/food/plant/pesticides/eu -pesticides -db_en  
80 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a 
European Chemicals Agency, amending Directive 1999/4 5/EC and repealing Council Regulation (EEC) No 
793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission 
Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).  
81 For previous s tatements follow the thread under ID 632 . G/TBT/M/88  
 
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  (BIS). The EU refers to its previous interventions but wou ld like to highlight that European industry 
continue to report the difficulties to work through the QCO.  
2.391.   The European industries indicates that the QCO remains challenging and the process is still 
very burdensome and complex. In addition, a huge concerns i s related to the fact that the import 
policy ( G/TBT/N/IND/143 ) has being applied on top of the QCO. To ensure the continued 
effectiveness of the Indian toy safety and quality regime under the QCO, the European Union would 
welcome that the Indian government considers clearly address ing and removing the current possible 
duplication of tests for QCO and at customs level under the DGFT notification for BIS certified 
products. According to recent information, we understand that now only the QCO is applicable and 
that the older regime is no longer in force and therefore there is no need of additional testing at 
customs anymore. However, we don't have a formal confirmation and we would welcome any further 
clarification in this regard. The European Union invites India to address the concerns  raised and to 
alleviate the requirement for factory audits overseas. The European Union remains available to have 
bilateral exchanges to find an adequate solution.  
2.392.   The representative of Canada  provided the following statement. As stated by Canada in 
previous TBT Committee meetings, the objective of India's quality control order regarding toys, as 
well as QCOs across many sectors, remains unclear. At the last TBT Committee, Canada was 
disappointed to hear that India reiterated the same response as in previo us TBT Committees failing 
to address any of Canada's and other Members' concerns. Canada would once again ask India to 
provide a substantive response and explain what specific actions it has taken since the last TBT 
Committee to address Members' concerns a nd what further actions are planned in the near future 
to have imports of toys into India resume normally.  
2.393.   In response, the representative of India provided the following statement. As per the 
provisions of the QCO, the products specified therein shall bea r a Standard Mark under a valid licence 
from BIS as per Scheme -I of the BIS (Conformity Assessment) Regulations, 2018. Under this 
Scheme, factory inspection is a mandatory requirement for the purpose of granting of licence. As 
per the product certification  scheme of BIS, the availability of in -house testing facilities with 
manufacturers is required to operate a licence. However, BIS has allowed relaxations for toys 
manufacturers, including permitting sub -contracting of tests to BIS -recognized laboratories. As per 
the product -specific guidelines for toys, sub -contracting of tests other than physical, mechanical and 
electrical safety is allowed. Sufficient capacity for testing of toys is available in BIS laboratories and 
laboratories recognized by BIS under it s laboratory recognition scheme (BIS LRS) for testing as per 
the relevant Indian Standards. Clause 12 of BIS LRS deals with the recognition of overseas 
laboratories.  
2.394.   The decision regarding recognition of overseas laboratories will be taken by BIS taking in to 
account the MRA (Mutual Recognition Agreement) with the concerned nation. Foreign inspections 
were on hold due to the prevalent restrictions on international travel imposed. As the COVID -19 
restrictions have eased out, BIS has started carrying out inspe ction where confirmation for travelling 
of fully vaccinated BIS officers has been received. BIS has nominated officers and applicants are 
asked to remit the inspection charges for carrying out inspection. On receipt of inspection charges, 
inspections are b eing planned. To date more than 350 preliminary inspections have already been 
carried out. However, if in some cases inspection are being delayed, it is due to difficulty in getting 
the visa. Further, it is to inform that BIS has already granted 24 licence s for toys after Covid period.  
2.1.4.43   Australia - Maturation requirements for imported alcohol (ID 63682) 
2.395.   The representative of Brazil  provided the following statement. Brazil continues to follow 
closely Australia's proposal to amend current regulations dealing w ith alcoholic beverages, and we 
would like to thank Australia for its response in the Committee's last meeting and for its engagement 
in bilateral talks. In past meetings, we have shared our concerns with Australian technical 
requirements applicable to cac haça, the Australian Customs Notice Nº 2007/19, which requires that 
some alcoholic beverages must be matured in wood for a minimum of two years before delivery 
from Customs control. This covers all beverages under tariff classifications 2208.20.10, 2208.30 .00 
and 2208.40.00. Even though said Notice only refers directly to brandy, rum, and whisky, it 
encompasses tariff line 2208.40.00 (rum and other spirits obtained by distilling fermented sugarcane 
products), under which cachaça is classified in Australia. By granting the same treatment to cachaça 
 
82 For previous statements follow the thread under ID 636 . G/TBT/M/88  
 
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  and rum, the Australian government does not allow imports of cachaça that are not matured for at 
least two years in wood. Such a requirement does not relate to any quality standard or sanitary 
requirement applicabl e to cachaça.  
2.396.   Following a public consultation in late -2019, the Australian Border Force (ABF) further 
explored a potential avenue to amend the Customs Act 1901 (Customs Act) that would enable the 
legitimate importation of certain alcohol products into Aust ralia whilst retaining the maturation 
requirements for brandy, whisky, and rum. According to a more recent public consultation, the 
Australian government is developing an approach that is looking to retain Australia's existing 
maturation requirement for im ported brandy, whisky, and rum, but would establish a list of products 
exempt from this maturation requirement. The proposed list of exempt products would include 
Cachaça, Pisco and Bourbon. Brazil acknowledges progress in the course of action proposed in the 
last public consultation. It is regrettable that this issue is already three years long without any 
technical justification for the requirements. We support the creation of a list of exceptions to the 
rules set out today in section 105A, thus allowing certain cultural and geographical indications (i.e. 
Cachaça) that are not traditionally described as brandy, whiskey or rum to be imported into the 
Australian market.  
2.397.   In order to avoid any confusion in the Australian market or among Australian consumers, 
we support that none of the sugar -cane products imported to Australia (matured or unmatured) that 
are not specifically "rum" should be labelled or marked as "rum". We kindly urge Australia to clarify 
the following points, which could not be addressed in its  previous statements. Could Australia please 
confirm if this new regulation will also establish new labelling requirements for products other than 
rum, brandy and whisky? Could Australia provide timeframes for the publication of the final text?  
2.398.   In response , the representative  of Australia  provided the following statement. We 
acknowledge Brazil's continuing interest in Australia's review of maturation requirements for certain 
imported alcohol products. Australia has convened a whole -of-government working gro up to 
consider concerns raised by trading partners regarding the maturation requirements for the 
importation of certain alcohol products into Australia and the domestic maturation requirements of 
brandy, whisky and rum. The working group is considering the  legislative framework for the 
importation of certain unmatured alcohol products under section 105A of the Customs Act 1901 . The 
whole -of-government working group is considering the legislative complexities and stakeholder 
concerns associated with this matter. The working group is comprised of Australian Government 
agencies to advise on a tried customs taxation and health aspe cts of imported certain unmatured 
alcohol products. The Australian Government will notify the Committee of any proposed legislative 
changes to section 105A of the Customs Act, and any other changes to alcohol import requirements 
in accordance with Australi a's obligation under the TBT Agreement.  
2.1.4.44   Panama - Onions and Potatoes Harvest Life and Sprouting Requirements, 
G/TBT/N/PAN/86 , G/TBT/N/PAN/102 , G/TBT/N/PAN/102/Add.1  (ID 66283) 
2.399.   The representative of the United States  provided the following statement. The United States 
is taking the floor for the eighth and final time in th e TBT Committee to share our concerns with 
Panama's measures affecting onions and potatoes. We are extremely disappointed that Panama 
finalized and began implementation of these technical regulations. Given our extensive attempts at 
constructive engagement  with Panama on this issue, including through requests made during 
technical meetings of our US -Panama Trade Promotion Agreement in May 2021, during eight TBT 
Committee meetings, in three meetings of the WTO Council for Trade in Goods, and at bilateral 
meetings in Panama, we are concerned that Panama has yet to provide a substantive response, 
particularly with regard to the lack of scientific and technical justification for these measures. 
Specifically, we remain concerned with Panama's harvest date require ments and prescriptive storage 
criteria for both commodities, neither of which appear to be based on science. Through its measures, 
it does not appear as though Panama has considered international standards and best practices, as 
suggested by the United St ates in comments submitted during the development of these technical 
regulations.  
2.400.   We, once more, ask that Panama meet its international and bilateral obligations, and we 
maintain our availability and commitment to work with Panama to refine these measures so that 
they meet Panama's legitimate objectives while not being unnecessarily trade restrictive. Despite 
 
83 For previous statements follow the thread under ID 662 . G/TBT/M/88  
 
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  our disappointment, we note that our bilateral engagements led Panama to delay implementation of 
the potato regulation several times. On one occasion,  Panama temporarily extended the harvest 
time window for onions from 90 days to 120 days. Beyond the measures in question, the United 
States is concerned that Panama is developing similar technical regulations to protect other sensitive 
products in Panama.  Importation of US onions, potatoes, and other products benefit consumers in 
Panama by increasing access to affordable and nutritious foods. Moving forward, we encourage 
Panama to remove unnecessary barriers to its market so that both Panama and the United  States 
can continue to enjoy the mutual benefits of trade between our two countries. The United States will 
continue to raise its concerns at the WTO Council for Trade in Goods. Additionally, we will continue 
supporting our trade partners who are also hur t by measures implemented by Panama that appear 
to lack justification. We reiterate our request that Panama suspend implementation of the potato 
and onion regulations until we have an opportunity to hold further technical discussions regarding 
these measur es. 
2.401.   The representative of Canada  provided the following statement. Canada would like to once 
again support this specific trade concern raised by the US regarding Panama's new quality 
requirements for fresh potatoes established by the Ministry of Industry a nd Commerce on 20 
February 2020. In its last intervention at the July 2022 WTO TBT Committee, Canada indicated that 
the new quality requirements, which have been implemented, have a direct impact on our ability to 
export potatoes to Panama. Unfortunately, this situation has not changed. As such, we continue to 
share the concerns raised by the United States and request that dialogue occur with Panama's 
Ministry of Commerce (MICI) to explore solutions relating to the restrictive time limits for storage 
and ma rketing, as well as the zero tolerance for sprouting. Canada respectfully requests again that 
Panama pause the enforcement of these requirements to allow for additional technical dialogue to 
occur and ensure that Panama's quality standards do not create un intended barriers to our mutually 
beneficial bilateral trade in agriculture.  
2.402.   In response, the representative  of Panama  provided the following statement. Panama would 
like to thank the United States and Canada for their comments; their concerns have been no ted. As 
mentioned by the delegation of the United States, Panama has been receptive to comments from its 
trading partners, as evidenced by the extension of the measure on onions. Panama reiterates its 
commitments to transparency and confirms that the Panam anian authorities are currently continuing 
to address this issue in the capital with all relevant government bodies, including the Ministry of 
Trade, the Panamanian Food Authority and the Ministry of Agriculture. We would like to reiterate 
that any update will be duly shared and communicated to this Committee.  
2.1.4.45   European Union - Wine labelling requirements – listing of importers for multiple 
destinations (ID 65984) 
2.403.   The representative of Australia  provided the following statement. Australia recognizes the 
EU's right to take measures necessary to protect human health and safety, by ensuring wine is 
labelled in a manner that is not misleading to consumers. Australia thanks the EU for their 
engagement to -date in this Committee and for the clarity they have provide d around the EU's wine 
labelling requirements. This issue remains an ongoing concern and barrier for Australia's wine 
industry, but we note the positive discussions that have taken place in the context of the Australia -
EU Wine Agreement and recognize this as an important forum where we may discuss this issue 
bilaterally. Further bilateral engagement with the EU is appreciated as we continue to work through 
this issue to ensure a mutually satisfactory outcome.  
2.404.   In response, the representative of the European Union  provided the following statement. 
The European Union thanks Australia for raising this issue. As explained in previous TBT Committees, 
according to EU rules, it is not possible to list "importers " for multiple destinations on the same wine 
bottle lab el. The EU and Australia may discuss this issue in the context of the EU -Australia FTA and 
Wine Agreement and explore whether a mutually satisfactory resolution can be found.  
 
84 For previous statements follow the thread under ID 659 . G/TBT/M/88  
 
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  2.1.4.46   Republic of Korea - Revision of Safety Conformation Criteria for Textile Products  
for Infants, G/TBT/N/KOR/ 678 (ID 65285) 
2.405.   The representative of the European Union  provided the following statement. The EU would 
like to recall its concerns raised in previous Committee meetings regarding the additional costs of 
testing infant clothing for the Korean market. The EU  acknowledges the importance of safety for 
infant products but is nevertheless trying to reduce the additional cost burden placed on overseas 
producers by allowing the conformity assessment of these products to the specific Korean 
requirement to be carried  out closer to their place of production. One example of this cost difference 
is an infant shirt with plastic buttons. The compliance costs in the KOTITI lab in Korea is five times 
higher in comparison with the same item for one of the biggest selling mark ets in the world. We 
note again that according to Article 22(7) of the Special Act on the Safety of Products for Children, 
a laboratory may conclude a contract with any domestic or foreign institution, which conducts tests 
and inspections on the safety of products for children subject to safety verification, to mutually 
recognize the results of tests and inspections on the safety of these products. According to Article  35 
of the Enforcement Rules of the Special Act on the Safety of Children's Products, ther e are three 
different ways by which a foreign testing agency could be enabled to conclude a contract to mutually 
recognise the testing results. Therefore, testing or inspection results carried out by overseas 
institutions can in principle be recognized. Th is possibility would allow for product safety verification 
to the specific Korean requirement for infant clothing to be performed outside of the Republic of 
Korea by internationally accredited laboratories. The EU urges the Republic of Korea to explore thi s 
solution, which would also reduce the environmental impact of shipping tonnes of clothing to Korea 
for testing.  
2.406.   In response, the representative of the Republic of Korea  provided the following statement. 
The Republic of Korea would like to thank the EU fo r its concerns and comments regarding the 
"Requirements for Textile Products for Infants" of Korea, and we would like to take this opportunity 
to respond to the request, which was raised by the EU at this TBT Committee. Textile products for 
infant under 36  months of age must be tested and inspected by a designated laboratory prescribed 
by the Special Act on the Safety of Products for Children to verify that the relevant product meets 
the safety standards specific to infant textile products. In such cases, w e would like to inform the 
Committee that a designated laboratory may enter into a contract for the mutual recognition of test 
results and inspections on verifying the safety of infant's textile products with a foreign laboratory 
or institution according t o Article 22(7) of the Special Act on the Safety of Products for Children and 
Article 35 of the Enforcement Rule of the Special Act on Products for Children. The contract for 
mutual recognition is a matter to be dealt with between the designated testing la boratory and a 
foreign testing laboratory or institution, and we inform you that if discussions between testing 
laboratories for a contract are made, the Korean government will faithfully fulfill its role under the 
Special Act on the Safety of Products for  Children. If necessary, we hope to have an opportunity to 
explain to the EU the requirements and procedures for mutual recognition of test results under the 
Special Act on the Safety of Products for Children. We very much hope to resolve the EU's concerns  
at this TBT Committee in a mutually beneficial manner.  
2.1.4.47   Kingdom of Saudi Arabia - Technical Regulation for limiting and restricting 
hazardous materials in electrical and electronic equipment, G/TBT/N/SAU/1166  (ID 
66686) 
2.407.   The representative of the United Kingdom  provided the following statement. The United 
Kingdom thanks Saudi Arabia for the continued constructive engagement on their notification which 
sets out its technical requirements for the restriction of hazardous substances in electrical and 
electronic equ ipment. The United Kingdom welcomes that Saudi Arabian authorities will now accept 
a Supplier's Declaration of Conformity. If implemented as described, acceptance of Supplier's 
Declaration of Conformity will be consistent with common international practice . It will also provide 
businesses with a less burdensome means of demonstrating compliance with the technical regulation 
than third -party conformity certification. The United Kingdom appreciates that Saudi Standards, 
Metrology, and Quality Organization (SA SO) stated in their previous written response to UK concerns 
that they will amend the implementation guidelines to reflect the acceptance of a Supplier's 
Declaration of Conformity. We would encourage Saudi Arabia to also amend the technical regulation 
 
85 For previous statements follow the thread under ID 652 . 
86 For previous statements follow the thread under ID 666 . G/TBT/M/88  
 
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  itself to reflect this change, and notify the updated text of the technical regulation and the amended 
guidelines to the TBT Committee in an addendum notification.  
2.408.   Where several regulations that require a Declaration of Conformity apply to a product, it is 
common international practice that the manufacturer is allowed to merge all these declarations into 
one document. We would be grateful if Saudi Arabia could confirm that Saudi Arabian authorities 
will accept a single Declaration of Conformity to cover all rel evant legislation. We have also been in 
touch to seek clarification on the conditions in which the statement of conformity from the supplier 
is accepted and look forward to receiving this. The United Kingdom thanks Saudi Arabia for their 
continued producti ve engagement, and we look forward to future correspondence with Saudi Arabia 
on this matter.  
2.409.   The representative of the United States  provided the following statement. The United States 
thanks Saudi Arabia for its continued engagement on the "Technical Reg ulation for the Restrictions 
of Hazardous Substances (RoHS) " for electrical and electronic equipment (EEE). As previously noted, 
we appreciate the decision to provide an extended and staged implementation period for the 
regulation, which began in July. We were also pleased by Saudi Arabia's July statement in this 
Committee indicating that a supplier declaration of conformity would be accepted under the RoHS. 
We would, however, like to see clarification on precisely who may use this declaration. Please furth er 
explain Article 5 -3 of the regulation and how an importer can utilize a supplier's declaration of 
conformity that has been submitted by a manufacturer or a manufacturer's legal representative in 
order to bring a product into the Saudi market. Please cla rify whether under the regulation, 
"manufacturer" includes, in addition to any natural or legal person who manufactures an EEE, an 
entity who has an EEE designed or manufactured and markets it under their name or trademark. 
Please clarify whether Annex 1 -B is a list of exemptions for use of the hazardous substances in 
monitoring and controlling equipment, similar to the list of exemptions for use of hazardous 
substances for other electrical and electronic equipment in Annex 1 -A. We look forwarded to 
continu ed bilateral discussions with Saudi Arabia as it moves forward with implementation and thank 
Saudi Arabia for its fulsome engagement - with governments and with private sector stakeholders - 
and for taking our comments into account.  
2.410.   The representative of Switzerland  provided the following statement. Switzerland would like 
to support the interventions made by previous speakers on the Kingdom of Saudi Arabia's Technical 
Regulation for limiting and restricting hazardous materials in electrical and electronic e quipment. 
Switzerland appreciates the Kingdom of Saudi Arabia's recent efforts to allow for a smooth 
implementation of the measures, such as the postponement of the application of the measures, the 
phased implementation, the issuance of a guidance document , the useful engagement with 
interested Members and stakeholders. We do also appreciate the Kingdom of Saudi Arabia's 
acceptance of suppliers' declaration of conformity under this technical regulation. Switzerland 
encourages the Kingdom of Saudi Arabia to continue to ensure that these requirements do not create 
unnecessary obstacles to trade: We would in particular welcome any additional clarifications as to 
the implementation of the requirements, in particular the modalities to use supplier's declaration o f 
conformity. Finally, Switzerland encourages the Kingdom of Saudi Arabia to continue engaging with 
interested stakeholders in order to support the implementation of these requirements.  
2.411.   In response, the representative of the Kingdom of Saudi Arabia  provide d the following 
statement. Kingdom of Saudi Arabia would like to thank the United Kingdom, United States, and 
Switzerland for their valuable comments on the Technical Regulation for Restriction of Hazardous 
Substances. Saudi Arabia is aiming at protecting human health and safety, and the environment, by 
regulating to ensure that hazardous substances are not above certain levels in consumer products 
such as Electrical and Electronic Equipment products. The Saudi Technical Regulations are developed 
in line wi th international practices and TBT good regulatory practices (GRP). On 10 August 2022, 
Saudi Arabia notified TBT secretariat with the addendum notification ( G/TBT/N/SAU/11 66/Add.2 ) for 
the technical regulation of Restriction of Hazardous Substances by accepting self -declaration for 
manufacturers or their legal representatives as a result of the bilateral engagement with the 
interested countries. Additionally, Saudi Standard s, Metrology and Quality Organization SASO 
circulated an announcement to all certification bodies (CBs) to apply the self -declaration.  
2.412.   Regarding the concern about who may use this declaration and how an importer can utilize 
a supplier's declaration of conf ormity, we would like to point out that all devices included in the 
regulation scope are covered by other regulations. Furthermore, RoHS regulation does not mandate 
a separate certificate, this means the products included in the scope of this regulation ar e also G/TBT/M/88  
 
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  included in the scope of other regulations. Therefore, the supplier is mandated to provide the 
conformity assessment bodies with the self -declaration. In addition, conformity assessment body 
must issue a single certificate for the product, which inc ludes all the technical requirements 
contained in the regulations to which the product is subject. It is the responsibility of the accepted 
conformity assessment bodies to ensure that all requirements are included in the technical file for 
products subject  to more than one technical regulation. Additionally, Annex (1 -a) and Annex (1 -b) 
of the Regulation, are exempted from Maximum Permissible Concentration Values by Weight in 
Homogeneous Materials for Hazardous Substances in Electrical and Electronic Equipme nt and 
Devices. In conclusion, Saudi Arabia is always delighted to collaborate and engage with all interested 
countries and stakeholders, in order to address related issues bilaterally.  
2.1.4.48   European Union - Commission Delegated Regulation (EU) 2019/945 on 
Unma nned Aircraft Systems and on Third -country Operators of Unmanned Aircraft 
Systems, G/TBT/N/EU/628  (ID 58587) 
2.413.   The representative of China  provided the following statement. China would like to thank the 
EU's reply to our concerns. We would like to further clarify why we believe the noi se limit 83dBA is 
safe enough, not noise pollution to people. The pilots who use C1 and C2 drones are exposed to the 
drones for a longer time and within a shorter distance than those the drones could potentially affect. 
If it is safe and not noisy for the pilots, it is more so for the latter group of people. Moreover, the 
flying duration of C1 and C2 drones is normally less than one hour due to battery endurance. So, 
even if the drone is used in residential areas, the short operation time is a guarantee not  to cause a 
continuous impact on people. We would like the EU to provide the basis or calculating formula for 
the noise limits of C1 and C2 drones to be set as less than or equal to 81dBA. Currently, we still 
recommend maintaining the 83dBA limit. We have given our evidence and reasoning at the last 
meeting. We stand ready for further discussion with the EU.  
2.414.   In response, the representative of the European Union  provided the following statement. 
Thank you to the Delegation of China for its comments on the dr aft Commission Delegated 
Regulation88 on unmanned aircraft systems, and on third -country operators of unmanned aircraft 
systems which was notified to the WTO on 9 January 2019 under G/TBT/N/EU/628 . Commission 
delegated Regulation (EU) 2019/945 on unmanned aircraft systems and on thir d-country operators 
of unmanned aircraft system and Commission Implementing Regulation (EU) 2019/947 on the rules 
and procedures for the operation of unmanned aircraft were published in June 2019. Regarding the 
noise requirement, the EU would like to draw the attention of the Delegation of China to the fact 
that those requirements apply to a limited number of products (C1 and C2 UAS). The objective of 
the requirement is not so much to protect the health of the drone pilot as to reduce noise pollution 
for ci tizens. Indeed, the societal acceptability of drone operations is essential to allow the 
development of their applications. It is therefore important to ensure that this development is 
accompanied by a gradual improvement in the performance of drones. This  is why the regulation, 
starting from the state of the art, imposes a progressive reduction of the noise limits taking into 
account the technical feasibility, even if this should induce some performance limitation. It is always 
possible for the manufacture r to put his drone on the market in class C3 for which no limit is set 
insofar as the operations must be carried out far from people.  
2.1.4.49   European Union - Withdrawal of the approval of the active substance alpha -
cypermethrin, G/TBT/N/EU/770 , G/TBT/N/EU/908  (ID 69489) 
2.415.   The representative of Brazil  provided the follow ing statement. Brazil would like to express 
its concerns related to European notification 770 regarding the Commission Implementing 
Regulation proposal to withdraw the approval of the active substance alpha -cypermethrin. Alpha -
cypermethrin is registered in  Brazil as an insecticide used against harmful pests that damage a 
variety of crops, including soy, cotton, corn, citrus, watermelon, peanut, coffee, among other 
products exported to the European Union. Withdrawal of the register of said substance and auto matic 
reduction of MRLs will significantly affect the income of Brazilian farmers, especially citrus producers. 
The substance is essential to control greening, a disease affecting citrus orchards worldwide. 
Greening has been recognized by EFSA itself as a priority pest for control, according to the 
 
87 For previous statements follow the thread under ID 585 . 
88 COMMISSION DELEGATED REGULATION (EU) 2019/945 of 12 March 2019 on unmanned aircraft 
systems and on third -country operators of unmanned aircraft systems.  
89 For previous statements follow the thread under ID 694 . G/TBT/M/88  
 
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  Commission Delegated Regulation (EU) 2019/1702. The Brazilian citrus industry plays an important 
role in generating jobs in the countryside. Export of orange juices to the European market 
represented almost USD 1  billion of exports in the 2019 -2020 marketing year.  
2.416.   Alpha -cypermethrin is also an important component to conduct integrated pest 
management, once it may be combined with other insecticides to contribute to increase their useful 
life, ensuring efficient pe st control and maintaining the sustainability of crop production. In light of 
the above, Brazil would like to kindly encourage the EU to adopt MRLs for imported products in 
accordance with the limits set under the Codex Alimentarius. Also, we would like to  consult if the EU 
may extend the approval of the active substance, which expired on 31 October. Such measure would 
minimize the impact on Brazilian citrus producers.  
2.417.   The representative of Kenya  provided the following statement. The EU has proposed new 
regulations withdrawing the approval of the active substance alpha -cypermethrin.  Kenya uses this 
product in plant protection, animal health as well as public health management. The proposed 
technical regulation will hurt Kenya which uses alpha -cypermethrin in  the management of plant pest, 
vectors of animal and public health importance. This measure, therefore, will undermine Kenya 's 
pursuit of legitimate objectives that is the protection of human health from tropical diseases as well 
as ensuring food security.  Kenya notes that the EU has allowed for emergency use of this active 
substance to some of its members owing to lack of alternatives. This is inconsistent with the non-
discrimination principle of the WTO and the provisions of Articles 2 and 5 of the TBT 
Agreement.  Products containing alpha-cypermethrin have been registered in Kenya and are used 
for: a. the control of Fall Army Worm (FAW) ; b. public health use for control of mosquitoes ; c. control 
of common insect pests such as lepidopterans in vegetables ; and  d. animal health for control of 
vectors like ticks . Fall armyworm is a threat to maize production and poses an additional threat to 
food and nutrition security for millions of people. This therefore calls for its control to reduce the 
menace.  Products containing alpha-cypermethrin are widely used to control public health pests such 
as mosquitoes, cockroaches, flies , etc. Public health remains an important part as it promotes and 
protects the health of people and the communities.  These products, when pro perly used, have not 
had any proven negative effects on humans. The EU measure therefore raises serious concerns of 
inconsistency with the TBT Agreement Art icle 2.2. The EU does not have sufficient scientific 
justification for it, and therefore needs to pr ovide scientific justification for the measure.  The 
regulation is more trade  restrictive than necessary . The EU measure therefore raises serious 
concerns of inconsistency with the TBT Agreement Art icle 2.2. Kenya requests the European Union 
to consider the withdrawal of the Regulation as the measure is more trade restrictive than necessary.  
2.418.   The representativ e of Paraguay  provided the following statement. Paraguay wishes to 
reiterate the importance of this substance in controlling pests that attack crops of great economic 
importance to the country, such as maize, soybean, sunflower and cotton.  In this regard, Paraguay 
once again requests the European Union to take into account, when reviewing the MRLs for this 
substance, information on pesticides provided by the specialized agencies recognized by the WTO, 
such as the Codex Alimentarius, reconsider its approach and base its decisions on conclusive 
scientific evidence and real risk weightings, in accordance with international standards and principles  
2.419.   In response, the representative of the European Union  provided the following statement. 
The EU thanks Brazil, Kenya , and Paraguay for raising this issue. As explained in previous TBT 
Committees, the approval of alpha -cypermethrin had to be withdrawn, as the Commission 
Implementing Regulation that renewed its approval in 2019 included the condition that the applicant 
had to submit confirmatory information as regards the toxicological profile of certain metabolites by 
30 October 2020. In addition, confirmatory information had been required for three other points by 
other deadlines. However, in October 2020, the applicant informed the Commission that it would not 
submit any confirmatory data. Therefore, as the information required in accordance with Article 6(f) 
of Regulation (EC) No 1107/200990 on plant protection products was not submitted and the applicant 
had clearly st ated that he will not fulfil his regulatory obligations, the approval for alpha -
cypermethrin had to be withdrawn according to Article 21(3) of Regulation (EC) No 1107/2009.  
2.420.   As regards Maximum Residue Levels (MRLs), a review of the whole group of cypermethr ins 
is currently ongoing by the European Food Safety Authority (EFSA). Existing Codex maximum 
 
90 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 
concerning the placing of plant protection products on the market and repealing Council Directives  79/117/EEC 
and 91/41 4/EEC. OJ L 309 24.11.2009, p. 1.  G/TBT/M/88  
 
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  residue limits and import tolerances will be considered in this review. EFSA intends to finalize the 
review in the second half of 2022. After that, the EU will co nsider the outcome and follow up on it, 
if appropriate. If there was a need for a specific measure on MRLs, such a measure would be notified 
to the WTO/SPS Committee. If Brazil and other Members consider it necessary to ensure that MRLs 
for alpha -cypermeth rin on relevant crops that were based on previous and now obsolete EU uses 
remain or should be newly set at higher/different levels, they may wish to submit an application for 
setting import tolerances according to Article 6 of Regulation (EC) No 396/200591 on maximum 
residue levels of pesticides in or on food and feed of plant and animal origin. The EU would like to 
invite Brazil, Kenya, Paraguay to contact the relevant authorities in Belgium, the Rapporteur member 
State, and to ensure that the necessary i nformation will be available in due time for the evaluation 
by the Rapporteur member State and EFSA.  
2.1.4.50   Belgium - Draft law introducing additional security measures for the provision 
of mobile 5G services, G/TBT/N/BEL/44 , G/TBT/N/BEL/45  (ID 71392) 
2.421.   The representative of China  provided the following statement. China  thanks the EU and 
Belgium for the reply. For the latest notification G/TBT/N/BEL/47 , China will provide comments soon. 
For the notification G/TBT/N/BEL/44 , we would like to reiterate our core concerns. Firstly, as the 
core content of the draft law, the risk assessment criteria neither relates to product charac teristics 
nor does it contain objective standards, and therefore is inconsistent with the requirements for 
technical regulations under the TBT Agreement. Also, Belgium could well have referred to 
international technical standards for 5G equipment safety as  legislation guidance. But they did not, 
which fails to conform to Article 2.4 of the TBT Agreement that requires using existing international 
standards as a basis for such technical regulations. Instead, the draft law assesses 5G product 
security based on  the vendors' identity and capacity, which are discriminatory and vague, lacking 
objectivity and impartiality. It violates relevant obligations set in Articles 2.1 and 2.2 of the TBT 
Agreement. Secondly, the draft law does not specify the scope and ways in  which the high -risk 
vendors are to be prohibited or restricted, nor does it illustrate a benchmark and legal remedies for 
high-risk vendors to seek a non -risk accreditation. Such practice denies procedural fairness and 
deviates from the general principles  of the WTO for trade laws and regulations to be enforced in a 
uniform, fair and reasonable manner. China urges compliance with the basic principles of the WTO 
and the specific requirements for technical regulations under the TBT Agreement and other releva nt 
WTO provisions, for the 5G equipment security standards and measures to be provided and applied 
in a fair and reasonable manner based on objective characteristics of the products, taking into 
consideration existing international standards and good pract ices in the industry. The vendors 
identified as high risk should be provided with sufficient ways for legal remedies.  
2.422.   In response, the representative of the European Union  provided the following statement. 
Thank you Chair. We thank China for its interest i n this measure and we look forward to China's 
upcoming comments on notification G/TBT/N/BEL/47 . As usual, China's comments will be duly 
considered in line with the recommendations of the WTO and the TBT Committee. Regarding the 
concerns about notification G/TBT/N/BEL/44 , we would like to refer back to our previ ous statement 
made during the July TBT Committee of this year.  
2.1.4.51   Republic of Korea - Regulation for supporting low carbon solar module product 
(ID 74493) 
2.423.   The representative of China  provided the following statement. Regarding the regulation for 
supporting low -carbon solar module products of the Republic of Korea, China would like to raise the 
following four points. Firstly, the life cycle assessment reports submitted by Chinese compa nies in 
accordance with ISO 14040 have not been recognized by Korea, while the reports based on the 
same calculation method have been recognized by EU member States. China hopes that Korea could 
explain its implementation criteria for reviewing LCA reports . If there are no such implementation 
criteria, the submitted reports should be reviewed in accordance with ISO and other international 
standards, and the report review process and requirements should be made public. Secondly, we 
hope Korea could publish t he list of qualified third -party certification institutions for companies to 
 
91 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on 
maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council 
Directive 91/41 4/EEC. OJ L 70, 16.3.2005, p. 1.  
92 For previous statements follow the thread under ID 713 . 
93 For previous statements follow the thread under ID 744 . G/TBT/M/88  
 
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  choose from. Thirdly, the review time of the report should be comparable to the time other Members 
take to review similar reports, which means completing approval within 30 days a fter acceptance, 
so as to improve efficiency. Fourthly, Chinese companies are required to submit much sensitive or 
trade secret information, which is unnecessary and unreasonable. We hope Korea could reasonably 
set the scope of data submission in accordanc e with international practices.  
2.424.   In response, the representative of the Republic of Korea  provided the following statement. 
Korea would like to thank the People's Republic of China for its continuous interests and statements 
regarding the "Regulation for su pporting low carbon solar module product" of Korea. Since the STC 
statement delivered today by China is a repetition of the previous statements, we kindly request 
China, for the time being, to refer to Korea's answers made at the last July TBT meeting. Fur ther, if 
China could provide more specific information regarding its difficulties (e.g., actual cases of 
certification delays, specifics of the trade secret or sensitive information, etc.), we will convey the 
information to the competent regulatory authori ty so that more detailed answer will be delivered to 
China. Korea asks for China's continued interest and cooperation to address this issue in a 
constructive manner.  
2.1.4.52   India - Approved models and manufacturers of solar photovoltaic modules order, 
2019 (ID 74 294) 
2.425.   The representative of China  provided the following statement. China believes India's 
Approved models and manufacturers of solar photovoltaic modules order, 2019 discriminates against 
foreign producers and products in terms of the review process, the r equirement on feedback time, 
and on sales terms, which places foreign producers in less favourable conditions and protects 
domestic producers. It is not consistent with the national treatment principle of GATT and Articles 
2.1, 5.1, and 5.2 of TBT. China s uggests that the Ministry of New and Renewable Energy (MNRE) of 
India and the National Institute of Solar Energy (NISE) adjust the measures, treat domestic and 
foreign companies equally, and publicize the audit process and time schedule so as to improve th e 
certification efficiency. In NISE's documentation and during the on -site verification process, the 
certification standards and rules are not clear, no guidance for the manufacturers, and no effective 
feedback and communication from the authorities in the  ALMM audit application process. It is against 
the transparency principle of GATT and TBT Articles 5.1, 5.2, and 5.6. Clear certification standards 
and auditing processes should be publicized.  
2.426.   After charging Chinese companies high fees for ALMM application  and testing, on -site 
inspection and audit have been delayed due to the COVID -19 pandemic. Considering the pandemic 
circumstances, particularly the travel restrictions, there should be alternative solutions to on -site 
inspection of overseas manufacturers, such as entrusting foreign certification bodies to conduct on -
site inspection accompanied by necessary remote video monitoring. Besides, we request India to 
postpone the implementation of the ALMM Act until 8 months after the completion of the on -site 
inspection. The fees charged for ALMM certification are unreasonable. Currently, ALMM certification 
fees are charged according to the total production capacity of the manufacturer, which is much 
higher than the actual export to India. It is against the obligat ion to control the fees in 
Article  VIII:1(a) of GATT and not to create unnecessary obstacles to trade in the TBT Agreement. It 
is recommended that India follow the agreement and set a reasonable price standard. The objectives 
of ensuring the quality of pho tovoltaic modules could well be achieved by BIS certification. To require 
ALMM certification is unnecessary, burdensome, and creating an obstacle to trade. It is against 
Article 2.2 of the TBT Agreement. We suggest India withdraw the ALMM order.  
2.427.   In respons e, the representative  of India provided the following statement. We have already 
provided a very detailed response on this STC in previous TBT meetings. This included, inter alia , 
why the proposed rules were neither discriminatory nor trade restrictive. We also explained in detail 
the GATT -conformance for the proposed rules. The Secretariat is requested to reflect the comments 
captured in G/TBT/M/87  in paragraphs 2.458 to 2.461 for this meeting as well. The BIS is 
undertaking onsite inspections where fully vaccinated BIS officers are able to travel and any delays 
are only due to the delays in procuring visa. The additional comments made today have been relayed 
to the capital for their consideration.  
2.428.   Statement from Ju ne 2022 meeting . 1. The Indian Government vide F.N0.283/54/2018 - 
GRID SOLAR "Approved Models and Manufacturers of Solar Photovoltaic Modules Order, 2019 ('ALMM 
 
94 For previous statements follow the thread under ID 742 . G/TBT/M/88  
 
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  Order') provides for enlistment of eligible models and manufacturers of solar PV cells and modul es 
complying with the BIS Standards and publish the same in a list called the "Approved List of Models 
and Manufacturers" (ALMM). The registration process and conditions prescribed are uniform 
irrespective of the nationality of the manufacturer. In other w ords, no distinction is made between 
domestic producers and overseas producers. There are no separate provisions for domestic 
producers and overseas producers with respect to review and feedback time. There may be some 
delay with respect to overseas produc ers due to logistical issues, however, the same cannot be 
considered as being discriminatory or unreasonable. India requests China to provide more details in 
this regard. India will review the information and provide its response.  
2.429.   2. India has published AL MM Order, Guidelines, Application formats and necessary FAQs on 
its website.95 The ALMM Order and Regulations are transparent and clearly spell out the process and 
the documentation requirements for enlistment under the ALMM List. However, India welcomes a ny 
suggestions on further improvement of the certification standard and process and will consider such 
suggestions with an open mind. 3. Foreign inspection visits were on hold due to restrictions on 
international travel because of the ongoing COVID -19 pand emic. As the situation of COVID -19 
improves and the restrictions are eased, inspections will be planned by NISE. There is no provision 
in ALMM Order or Regulations for remote assessment or any other means for inspection. 4. Under 
the ALMM Order and Guideli nes, a standard fee has been prescribed for all entities which wish to 
enlist under the ALMM scheme. The said regulation states as under:  
2.430.   3.1 The application fee for one model of module /cell shall be Rs. 5,000/ - per MW of the 
total installed manufacturing  capacity for solar PV modules and Rs. 5, 000/ - per MW of the total 
installed manufacturing capacity for solar PV cells, of the applicant. However, as a measure of further 
facilitation to small manufacturers, for PV module manufacturers having total instal led 
manufacturing capacity less than or equal to 50 MW, the application fee for one model of module is 
Rs.2,500/ - per MW of the total installed manufacturing capacity for solar PV modules, of the 
applicant. 3.2 The "model" as mentioned in (3.1) above, refe rs to modules / cells of same nominal 
power output rating. All BIS approved modules/ cells of the applicant with same nominal power 
output rating shall be treated as one model. 3.3 In case the application consists of multiple models, 
the application fee sh all be as per 3.1 above for one model and additional 1% of this for every 
additional model. 4.1 The fee has been determined based on total installed manufacturing capacity 
as ALMM is intended in respect of manufacturer and total capacity and not actual pro duction or 
export quota. It is also important to note that the said application fee and other charges are uniform, 
irrespective of nationality of the producer — whether Indian or overseas producers. 4.2 Article 
VIII(1) (a) of GATT 1947 states that "All fee s and charges of whatever character (other than import 
and export duties and other than taxes within the purview of Article III) imposed by contracting 
parties on or in connection with importation or exportation shall be limited in amount to the 
approximat e cost of services rendered and shall not represent an indirect protection to domestic 
products or a taxation of imports or exports for fiscal purposes." 4.3 As stated above, the application 
fee charged under ALMM regulations is commensurate with the servi ces provided and is uniform 
irrespective of nationality of the producer. Thus, the application fee cannot be considered as an 
indirect protection to domestic products or as charges additional levied only on imports. 4.4 Thus, 
India considers that the appli cation fee charged under ALMM regulations is consistent with 
Article  VIII (1) (a) of GATT 1947 and the said fee is unlikely to cause unreasonable burden or 
restrictions on international trade.  
2.431.   5. The BIS certification requirement deals with quality control  of the solar cells and modules. 
The ALMM Order provides for enlistment of eligible models and manufacturers of solar PV cells and 
modules complying with the BIS Standards. While BIS certification is with respect to maintaining the 
quality of the product p er se, ALMM certification intends to enlist eligible models and manufacturers, 
producing the said solar cells and modules. ALMM is thus, aimed to ensure the reliability of the 
producers of the enlisted models. Thus, ALMM and BIS certifications are reasonab le requirements in 
the larger public interest to ensure quality of the product as well as ensure reliability of the producer. 
ALMM intends to plug this aspect to ensure protect consumer interests and ensure larger energy 
security of the country, which BIS does not provide.  
 
95 https://mnre.gov.in/solar/manufacturersand -quality -control .  G/TBT/M/88  
 
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  2.1.4.53   India - Plastic Waste Management (Amendment) Rules, 2021 and 2022 (ID 
71996) 
2.432.   The representative of the United States  provided the following statement. We continue to 
have concerns with India's Plastic Waste Management (Amendment) Rules, 2 022 (PMW Amendment 
Rules). Unfortunately, India did not address our questions as raised at the July Committee meeting, 
and so we refer India to our previous statement. We are also aware that US stakeholders have 
requested further clarification on some of t he terms, provisions, and categorizations in the PWM 
Amendment Rules in order to effectively comply with the measure. For example, stakeholders have 
noted the need for clarification on: (i) reporting obligations of impacted sectors and the 
corresponding pr ocess administered by the Ministry of Environment, Forest and Climate Change; 
(ii) the Extended Producer Responsibility (EPR) fee calculation, especially in cases in which a 
company is not able to take back or collect the retail packaging; and (iii) how pr oducers, importers, 
and brand -owners can meet their EPR obligations pursuant to section 8.3 by purchasing surplus EPR 
certificates from other producers, importers, and brand owners of the same category and how certain 
packaging is classified in the four ca tegories listed in section 5 of the measure. For example, what 
category (I, II, III, or IV) would packaging such as blister packs and shrink/transport wrap film fall 
under?  
2.433.   We understand from guidance published by the Ministry of Environment, Forest, and C limate 
Change that the regulation went into effect on 1 July 2022. While we support India's objective to 
mitigate pollution caused by plastic waste, we have concerns as to the implementation of this 
measure given the lack of notification and formal input f rom stakeholders and WTO Members. At the 
July Committee meeting, India noted that these rules were not discriminatory and not a barrier to 
trade, but that is not an exception to India's obligation to notify technical regulations that may have 
a significant  effect on trade. We again urge India to notify this measure to the WTO TBT Committee.  
2.434.   In response, the representative of India provided the following statement. We thank the 
delegation of the USA for their continued interest in this issue. The Plastic Wa ste Management Rules, 
2016, provides India's statutory framework for plastic waste management. Rule 4 of the Plastic 
Waste Management Rules, 2016, provides a minimum thickness requirement for plastic carry bags 
and plastic sheets used in packaging. Rule 9 casts Extended Producer Responsibility on Producers, 
Importers and Brand Owners for environmentally sound management of Plastic packaging 
introduced in the market along with the products. Since 2016, the EPR targets already were 100% 
plastic packaging intr oduced in the markets. The EPR targets have been arrived at after undertaking 
statutory consultation with stakeholders in the country. The EPR targets are achievable given the 
amount of plastic packaging introduced annually. The EPR Guidelines have provide d for establishing 
a committee that reviews the implementation of EPR Guidelines and can suggest amendments as 
required. The EPR Guidelines have provided staggered EPR targets as given below: 2021 -22: 25%; 
2022-23: 70%; 2023 -24: 100%. The targets for recyc ling plastic waste, reuse of rigid plastic 
packaging and using recycled plastic content are also staggered. The category -wise target for 
recycling plastic packaging comes into effect in 2024 -25. The target for the reuse of rigid plastic 
packaging and the u se of recycled plastic content in plastic packaging comes into effect in 2025 -26. 
Adequate transition time has been given to the industry. The category -wise targets come into effect 
from 2024 -25. This will allow further development of waste management and recycling 
infrastructure.  
2.435.   Central Pollution Control Board publishes Annual Report on plastic waste management, which 
is in the public domain. Requisite assessment has been made while framing EPR targets. The list of 
registered recyclers is also available i n the public domain on the centralized EPR portal. The annual 
returns will be filed by producers, importers and brand owners through the centralized EPR portal 
developed by CPCB. The Guidelines for Environmental Compensation concerning Plastic Waste 
Manage ment are already in place. These are being updated by CPCB and will be notified following 
due process. The transaction of EPR certificates will be reflected on the centralized EPR portal 
developed by CPCB. Category -wise classification of plastic packaging is based on physical form and 
constituents packaging material. The user may make assessments as per definitions notified in 
Plastic Waste Management Rules, as amended. The roles and responsibilities of State Pollution 
Control Boards concerning plastic wast e management are stated in the rules. The EPR Guidelines 
are not discriminatory and do not put in place any non -tariff barrier. The requirements apply 
 
96 For previous statements f ollow the thread under ID 719 . G/TBT/M/88  
 
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  uniformly to domestic and international companies. It is a measure to reduce pollution caused by 
littered  and unmanaged plastic waste. Many countries have already brought in such measures.  
2.1.4.54   Sri Lanka - National Environmental (Plastic Material Identification Standards) 
Regulations No. 01 of 2021 (ID 71197) 
2.436.   The representative of the United States  provided the fo llowing statement. We appreciate Sri 
Lanka's statement at the July TBT Committee meeting that the regulation has yet to be finalized, 
and it is committed to notifying the final regulation and implementing guidelines. We would, 
however, encourage Sri Lanka to notify the regulation and implementing guidelines at an early 
enough stage to allow Members and stakeholders to provide their comments and have those 
comments taken into account before the regulation and implementing guidelines are finalized. We 
look fo rward to reviewing Sri Lanka's notification and will continue our conversations outside of this 
Committee in the meantime. We would like to thank Sri Lanka for sharing its draft implementation 
guidelines for the PMI Regulation. We appreciate your time work ing with us.  
2.437.   In response, the representative of Sri Lanka  provided the following statement. Sri Lanka 
would like to thank the delegation of the United States for its continuous interest on Sri Lanka's 
regulation on National Environmental Plastic Material I dentification Standard No.01 of 2021. As my 
delegation informed at the previous TBT meetings, though this regulation has been published, it has 
not yet been enforced since the implementation guidelines are still to be finalized. The Central 
Environmental A uthority has drafted implementation guidelines in consultation with the industrial 
sector. For this purpose, Sri Lanka has received certain technical assistance, especially from Cefas 
(Centre for Environment, Fisheries and Aquaculture Science). However, th e authorities have 
informed that they need further technical assistance to frame and finalize the implementation 
guidelines. Therefore, there is currently an unexpected delay in finalizing the guidelines. Once the 
guidelines are finalized, Sri Lanka will a rrange to notify the final Regulation along with the 
implementation guidelines to the TBT Committee for Members' comments before its legal 
enforcement. My delegation has taken due note of the concerns expressed by the delegation of the 
United States today which will be conveyed to our national focal points for their consideration.  
2.1.4.55   France - Decree on the minimum proportion of re -used packaging to be placed 
on the market annually, G/TBT/N/FRA/223  (ID 75898) 
2.438.   The representative of the United States  provided the following statement. The United States 
supports France's objectives of increasing the availability of reusable packaging and reducing 
pollution caused by packaging waste in the environment. Our industries have expressed strong 
concerns about the feasibility of complying with this Decree, and the proliferation of member State -
specific measures on packaging, labelling, and waste sorting rules that vary across the EU. In our 
July bilateral meeting, France noted that the Reuse Observatory, within the Ecological Transition 
Agency, will engage in a dialogue with stakeholders and that implementation guidelines will be 
released to facilitate compliance with the Decree. Is the stakeholder dialogue open to US industry 
representatives? We understand that the Decree was adopted on 8 April 2022,  and originally was to 
enter into force on 1 January 2023. However, in the written answers we received to our previous 
questions in June, France indicated that the implementation guidelines are not expected to be 
published until the end of 2022. Will the i mplementation date be delayed to allow Members and 
industry stakeholders a reasonable time to become acquainted with the guidelines and adapt their 
products or methods of production to the new requirements?  
2.439.   It is our understanding that the Decree provides a mechanism for producer compliance 
through participation in eco -organizations related to packaging. In that case, would it be up to 
companies to determine which of their products are best suited to reused packaging to meet the 
target thresholds, or will t he eco -organizations mandate which products must have reusable 
packaging? It is our understanding that the European Commission is working on a revision to its 
Packaging & Packaging Waste Directive (P&PWD). How would France's measure be impacted by the 
revised Directive if there are differences between the two measures? Given the limited engagement 
on our specific concerns on this measure at the last meeting, and the fact that the EU is working on 
 
97 For previous statements follow the thread under ID 71 1. 
98 For previous statements follow the thread under ID 758 . G/TBT/M/88  
 
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  revisions to its P&PWD which may impact this final regulation , we will continue our engagement 
bilaterally instead of on the floor of the TBT Committee.  
2.440.   The representative of Australia  provided the following statement. Australia recognizes 
France's right to take measures necessary to prevent waste and promote sustainable practices by 
increasing the availability of reusable packaging. Australia thanks France for notifying Members of 
this measure in March this year (in G/TBT/N/FRA/223 ). Australia shares the concerns outlined by 
other WTO Members in the July Committee meeting and expresses concern around the limited 
consultation that was conducted. Australia would like to seek clarity on whether this decree will app ly 
to imported products in the same way it will apply to domestically produced products. If it applies 
to imported products, we would appreciate further detail on the implementation of the decree; in 
particular, how it will affect trade in wine and whether  it will disproportionately impact imported 
products.  
2.441.   The representative of Argentina  provided the following statement. The Decree by France in 
document G/TBT/N/FRA/223  establishes the obligation to recycle a certain percentage of containers 
and packaging, increasing over time, in order to reduce waste and move towards a circular economy. 
Accordingly, it establishes deadlines and procedures for those within the supply chain to organize 
themselves to comply with this obligation. The definition of producer includes importers, which is  
why, although this is not specified, the Decree could affect wines exported to France. Argentina is 
therefore concerned about this measure and wishes to consult France once again on the scope of 
this Decree in relation to imported products, how it intends  to apply it to imported products and 
whether this does not amount to an extraterritorial application of a provision that aims to reduce 
waste and recycle in order to protect the environment.  
2.442.   In response, the representative of the European Union  provided t he following statement. 
The EU would like to thank the United States, Australia, and Argentina for their comments on this 
notification. To answer the practical questions raised by the United States: The work conducted by 
the Reuse Observatory to develop gu idelines is accessible to all the professional federations 
concerned by the decree. As such, organizations representing American companies concerned by 
this decree can participate in this work by simple request to the Reuse Observatory, set -up within 
the French Ecological Transition Agency. To date, there are no plans to postpone the 2023 targets 
for companies with an annual turnover of more than 50 million euros. However, as 2023 will be the 
first year of the entering into force of the decree, any controls  will be conducted with a flexible and 
educational objective in mind. The decree provides that the obligations imposed on a manufacturer 
in relation to the extended producer responsibilities are transferred to the eco -organization in the 
event that the man ufacturer joins such an eco -organization. The objectives pursuit by the decree 
are then attributed to the eco -organisation, which must take the necessary measures, in particular 
regarding eco -modulation criteria, to achieve these objectives. The annual tar gets for the eco -
organisation will then correspond to the sum of the individual targets on each of its member 
manufacturers. When a new version of the EU Packaging and Packaging Waste Directive is adopted, 
the provisions of the decree will be adjusted as n ecessary. Finally, to answer Australia's question: 
the decree applies equally to packaging produced in France and to imported packaging.  
2.1.4.56   India - Alert Regarding Implementation of QR Code for Refrigerators (ID 75799) 
2.443.   The representative of the Republic of Ko rea provided the following statement.  The Republic 
of Korea appreciates this opportunity to make comments on the "Implementation of QR Code for 
Refrigerators" (hereinafter, the 'Regulation') by the BEE (Bureau of Energy Efficiency) of India. Korea 
would a lso like to thank India for its response statement at the last July 2022 WTO TBT Committee 
meeting. However, Korea would like to reiterate its concerns as the Korean industry still faces 
unresolved difficulties regarding the Regulation. According to the do cument published on 31 March 
2022 by BEE, the requirement to affix a QR Code below the BEE Star Label on each unit of refrigerator 
will become mandatory from 1 January 2023. At the last July meeting, Korea commented that India 
neither notified the WTO of t he Regulation nor provided the Members with time to make comments, 
to which India responded that various stakeholders, including the Korean manufacturers registered 
with the BEE of India, had been given sufficient opportunities to make comments and partici pate in 
discussions and that "No formal notification through other platform is required for implementation 
of the QR code under S&L (Standards & Labelling) Program."  
 
99 For previous statements follow the thread under ID 757 . G/TBT/M/88  
 
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  2.444.   However, apart from providing such opportunities domestically, we would like to remind 
India of its obligations under Articles 2.9.2 and 2.9.4 of the WTO TBT Agreement to notify other 
Members of the proposed technical regulation and allow reasonable time for them to make written 
comments. Therefore, Korea requests again that India kindly provid e the Members with a period for 
commenting in accordance with the TBT Agreement. Moreover, Korean companies consider that they 
need at least 12 months to adapt their products for QR Code labelling requirements. Therefore, 
Korea requests that India first ca rry out the formal notification and provision of a period for 
commenting, and then implement the Regulation after a transition period of 12 months from the 
publication date of the final text. Secondly, India requires the QR Code to be assigned per serial 
number of each refrigerator unit whereas, other countries such as the EU, UK, Türkiye, China, and 
Saudi Arabia require the QR Code assigned per product model name. Such requirement unique to 
India is excessive and overly burdensome for the manufacturers to satisfy. Therefore, Korea requests 
that India improve the Regulation so that the QR Code labels are generated per the model name 
rather than per each serial number of the product. Lastly, the QR Code Request & Approval system 
in BEE's online Portal does no t allow the submission of requests for additional QR label generation 
until the data upload for all of the previously requested QR labels is completed. No other countries 
apply this kind of submission restriction which makes the Regulation excessive and di fficult to comply 
with. Therefore, Korea requests that India improve the online system so that additional requests can 
be submitted and processed regardless of the upload status of the previously requested QR labels' 
data. 
2.445.   In response, the representative o f India provided the following statement. We thank the 
delegation of Korea for their continued interest in this issue. Since the substance of today's 
comments are the same as in the last meeting, we refer to our past statement captured in the 
document G/TBT/M/87  in paragraphs 2.37 and 2.38 a nd request the Secretariat to reflect the same 
in today's statements as well. We have conveyed the additional points raised by Korea to the capital 
and these are currently being reviewed.  
2.446.   Statement from June 2022 meeting . The energy performance benchmarks (star rating 
levels) under Standards & Labelling (S&L) programme are implemented by Bureau of Energy 
Efficiency (BEE) in accordance with Section 14 of the Energy Conservation Act, passed by the 
Parliament of India. The regulatory mechanism of th e S&L programme encompasses a provision of 
Monitoring and Verification, under which, BEE has proposed to implement the secure QR code along 
with star label on the appliance/equipment in order to enable authenticate/validate the star rating 
specifications o f the label by the consumer himself. The discussion for implementation of QR Code 
on refrigerators was initiated during the year 2019. In this regard the first meeting of stakeholders 
including manufacturers of product from various countries including Kore a was held on 5 November 
2019 wherein, workflow and the effective timelines for 1 March 2020 was announced and circulated 
to the stakeholders including the Korean manufacturers registered with BEE under S&L programme. 
However, the implementation timeline o f the QR code got delayed due to the COVID -19 pandemic 
situation. Further, during the year 2021, the new timelines of 1 January 2023 was communicated to 
all the stakeholders through virtual meetings. Various comments and inputs received from the 
manufactur ers on the workflow of QR code were addressed by BEE from time to time.  
2.447.   Subsequently, BEE had issued a formal alert during March 2022 on the mandatory timeline 
for Implementation of QR code with effect from January 2023. This alert was issued based on the 
request received from manufacturers to issue a formal announcement before eight to  nine months 
from the date of issue of the Gazette notification. The energy performance benchmarks (star rating 
levels) under Standards & Labeling (S&L) programme are implem ented by Bureau of Energy 
Efficiency (BEE) in accordance with Section 14 of the Energy Conservation Act, which is passed by 
the Parliament of India. As such, no formal notification through other platform is required for 
implementation of the QR code under S&L program. Further, it may please be noted that, few 
manufacturers have successfully completed the pilot run in the month of May 2022. The objective 
of implementation of QR code is to authenticate / validate the star rating specifications of the label 
to protect the interest of consumers. It may be noted that, generation of QR code by model name 
rather than by serial number of each unit of refrigerator may defeat BEE's purpose of validating the 
credibility of star label affixed on each unit / product of r efrigerator being purchased by the 
consumer.  G/TBT/M/88  
 
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  2.1.4.57   France - Order specifying the substances contained in mineral oils the use of 
which is prohibited in packaging and in printed matter distributed to the public, 
G/TBT/N/FRA/216  (ID 756100) 
2.448.   The representative of China  provided the following  statement. China supports France's 
implementation of its requirements for mineral oil control, but from the perspective of not creating 
unnecessary trade barriers, China makes the following suggestions. First, we suggest France clarify 
the detection metho d of mineral oil. The Order does not prescribe the method of testing mineral oil, 
so the company has no unified inspection standard for conducting compliance inspections. Whether 
the results of the test conform to the requirement is therefore questionable.  Secondly, clarify the 
types of packaging. As the regulation does not specify the types of packaging, it may affect a wide 
range of packaging for food, drug, toy, electronic and electrical products, etc. It is recommended to 
clarify the packaging types to facilitate better compliance of enterprises. It is also recommended 
that a guiding document could be issued for the management of packages and printed matters that 
have already been printed. For printed packaging and printed matter, apart from the ink, pac kaging 
and printed materials may also contain mineral oil which can be introduced in the production process. 
It may be possible that printing inks with mineral oil comply with the requirements of the order, 
while printed packaging and printed products with  mineral oil content exceed the limits of the Order.  
2.449.   The representative of the United States  provided the following statement. The United States 
supports France's objective of combatting waste and limiting the use of non -recyclable material. The 
United Sta tes also appreciates the continued engagement on this Order. At July's TBT Committee 
meeting, we urged France to take into account stakeholder comments regarding their ability to meet 
the proposed timeline. We were therefore pleased to note France's indica tion that it will delay 
implementation of certain aspects of this Order until 2025 and will establish a Working Group to 
consider additional revisions. While we support these developments, we continue to have questions 
regarding the specifics of the draft regulation and remain concerned that aspects of this Order may 
be more trade restrictive than necessary to fulfill France's legitimate objective. For example, it is 
our understanding from industry that it is currently not possible to test for the levels of  aromatic 
hydrocarbons at the mass concentration thresholds that will be permitted in packaging from 
1 January 2025 (lower than one part per billion). Has France considered the current technology 
available for testing and how it plans to enforce the order if the required technology does not yet 
exist? We ask that France take into account stakeholder comments regarding its ability to meet the 
proposed timeline. Given that the EU is working on revisions to its Packaging and Packaging Waste 
Directive, and impl ementation of this measure has been extended to 2025, we will likely pursue 
bilateral discussions on this matter for the time being, outside of this Committee.  
2.450.   In response, the representative of the European Union  provided the following statement.  
Regardi ng the testing methods, we would like to clarify that the French Order does not prescribe 
specific test methods to demonstrate conformity. According to Article R.543 -49 of the Environmental 
Code, the demonstration should be based on the production of writt en or technical documents. 
Therefore, a working group will be set up in order to identify difficulties as well as available solutions 
by the 2025 deadline. Appropriate solutions to demonstrate compliance will be discussed as well.  
2.1.4.58   European Union - Proposal  for a Directive of the European Parliament and of the 
Council amending Directive 2014/53/EU on the harmonization of the laws of the Member 
States relating to the making available on the market of radio equipment (COM/2021/547 
final), G/TBT/N/EU/859  (ID 750101) 
2.451.   The representative of t he United States  provided the following statement. The United States 
and EU have discussed this proposed regulation at length bilaterally, and we raised concerns during 
the July 2022 Technical Barriers to Trade Committee. Our understanding is that the EU's  proposal 
for a common charger was finalized on 4 October 2022. We note our dissatisfaction around certain 
elements of what we understand is the final version of this law. In principle, we continue to support 
technical regulations that allow products to me et existing international standards. The prescriptive 
nature of this proposal conflicts with manufacturers' ability to choose such standards. We urge the 
EU to specify technical regulations based on product requirements in terms of performance rather 
than design characteristics. The EU's inclusion of new products in the proposal's scope late in the 
drafting process allowed little time for stakeholders to provide input. The TBT Committee 
 
100 For previous statements follow the thread under ID 756 . 
101 For previous statements follow the thread under ID 750 . G/TBT/M/88  
 
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  recommends revised proposed technical regulations to be notified as a r evision with a new sixty -day 
comment period. That way, comments can be considered on the new elements of the draft. Since 
the measure is final, this will be our last intervention on the floor, and note that our comments that 
encouraged the use of relevant international standards were not taken into account.  
2.452.   In response, the representative of the European Union  provided the following statement. 
Thank you to the United States for its continued comments on this notification. As mentioned, the 
proposal was adop ted in first reading by the European Parliament on 4 October 2022 and confirmed 
by the Council on 24 October 2022. Regarding United States' concern about imposing the integration 
of the USB Type -C receptacle for certain categories or classes of radio equip ment, the EU would like 
to emphasize again that, for more than 10 years, the European Commission has supported a 
voluntary approach for industry. This was ineffective in solving the lack of interoperability between 
radio equipment and chargers still causin g inconvenience for consumers. The harmonized charging 
receptacle (USB -C) is a technology that has been and is developed by a consortium that includes 
major ICT manufacturers. Their specifications are open and translated into international and 
European sta ndards, the latter are the ones referenced in the text and will be continuously monitored 
and updated, if necessary, via an appropriate mechanism. Specifying the technical requirements in 
terms of design characteristics is the only possible way to achieve full interoperability between radio 
equipment and chargers (consumer convenience) and reduce the proliferation of unnecessary 
chargers (environmental benefits). Combining a harmonised charging solution with the unbundling 
of the external power supply will deliver results only if each category of products covered is equipped 
with the same receptacle.  
2.1.4.59   Viet Nam - Cybersecurity Measures (ID 544102) 
2.453.   The representative of Japan  provided the following statement. Japan has concerns about the 
Cybersecurity Law, stip ulating unclear standards and requirements for security assurance obligations 
of devices and systems, which may impose an undue burden on business enterprises. If it is found 
to be more trade restrictive than necessary to achieve legitimate objectives, it may violate the TBT 
Agreement. In regard to this point, Japan has submitted comments on this law, which was enforced 
in January 2019. We are aware that the Decree No.53/2022/ND -CP ("Decree 53 ") has been in effect 
since this October. Decree 53 imposes the o bligation to store data within Viet Nam on not only 
domestic enterprises but also foreign enterprises providing online services to users in Viet Nam. 
Moreover, this Decree obliges such foreign enterprises to establish a branch or representative office 
in Viet Nam. We are concerned that there is a high possibility that foreign enterprises will be put at 
a de facto competitive disadvantage compared to domestic enterprises, since foreign enterprises are 
likely to incur an additional burden related to the insta llation of servers to store data within Viet Nam 
and the establishment of branch offices, which Decree 53 requires. Japan would like to request that 
Viet Nam take appropriate measures to address these concerns, taking into consideration the voices 
of the i ndustries. In addition, the period from the promulgation of this Decree to its enforcement 
was quite short (approximately six weeks), and it is difficult to say that foreign enterprises have had 
sufficient time to prepare to comply with Decree 53. From a b usiness perspective, predictability and 
transparency of laws and regulations including Decree 53 are very important, and from the 
perspective of aiming to improve the investment environment, Japan would like to request that Viet 
Nam implement laws and regu lations appropriately, without hindering business.  
2.454.   In response, the representative of Viet Nam  provided the following statement. Viet Nam's 
Law on Cybersecurity provides obligations to ensure the security of equipment and systems that 
apply only to informa tion systems important to national security in Viet Nam and not to the system 
of enterprises, so it does not impose burdens on enterprises. According to Article 26 of Decree no. 
53/2022/ ND -CP, which details a number of articles of the Law on Cybersecurity , foreign companies 
may store data and establish branches or representative offices in Viet Nam only if the services 
provided by the companies are used to commit acts that violate the Law on Network Security and 
have been reported by the Department of Cybe rsecurity and High -Tech Crime Prevention and Control 
of the Ministry of Public Security and requested in writing to coordinate, prevent, investigate and 
deal with, but fail to comply or fully comply, or prevent, hinder, disable or override network security  
protection measures taken by specialized network security forces. This regulation granted companies 
the right to decide on this issue. Viet Nam believes that the provisions of the Law on Cybersecurity 
 
102 For previous statements follow the thread under ID 544 . G/TBT/M/88  
 
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  and Decree No. 53 do not impede the flow of data and d o not impose an additional burden if 
enterprises comply with Viet Nam's cybersecurity laws.  
2.1.4.60   Colombia – Good manufacturing practices of overseas production 
establishments, G/TBT/N/COL/242  (ID 697103) 
2.455.   The representative of the European Union  provided the following statement.  The Euro pean 
Union would like to thank Colombia for its reply of November 2020 to the EU written comments and 
for the extensive bilateral discussions. The European Union notes that Article 3 of the Decree no 162 
published on 16 February 2021 refers to the possibil ity to present alternatives to the Good 
Manufacturing Practices certificate upon import to Colombia. EU exporters of wines and spirit drinks 
already comply with the existing obligation to submit Free Sales Certificates for sanitary register. 
The Free Sales  Certificates state that the product is compliant with the EU legislative requirements, 
which encompass Good Manufacturing Practices. The European Union therefore considers that Free 
Sale Certificates issued by EU member States would comply with the Colomb ian requirement to 
provide Good Manufacturing Practices certificate upon import. Consequently, we wish to reiterate 
our request to Colombia to accept all EU FSCs for the purpose of GMPs and amend the relevant 
Decree accordingly as a matter of urgency.  
2.456.   As the time left for the entry into force of these requirements is getting shorter, the European 
Union is indeed increasingly concerned about negative impact this measure could have on its exports 
of wines and spirits, especially from SMEs, should not all its  Free Sale Certificates be accepted. 
Therefore, the European Union is prepared to continue the bilateral work should there be any need 
for additional clarifications. As a possible temporary solution awaiting the possible amendments to 
the Decree, INVIMA co uld instruct its inspectors through internal guidance that all EU FSCs indicating 
compliance with EU legislation, cover the product and the producer. Lastly, we note that Colombia, 
by means of Decree 1366/2020, has delayed the entry into force of these cer tification requirements 
for its own small producers of alcoholic beverages. Until a final solution is identified, we would kindly 
request to postpone the entry into force of the Decree 162/2021 till 2025 to avoid any discrimination 
between foreign exporter s and domestic industry.  
2.457.   In response, the representative of Colombia  provided the following statement. With regard 
to this trade concern, Colombia would like to highlight the work being carried out by the Colombian 
health authorities in conjunction with th e countries concerned to clarify the concerns raised about 
compliance with Decree No. 162 of 2021, issued by the Colombian Ministry of Health and Social 
Welfare. It is of the utmost importance to pursue these collaborative efforts, particularly in relation  
to certificates of good manufacturing practices for alcoholic drinks intended for human consumption. 
Therefore, and as a result of recent meetings, the Colombian National Food and Drugs Surveillance 
Institute (INVIMA) has been providing feedback about the  certificates it has received from the 
interested countries, in order to check the status of compliance with the technical requirements. We 
stand ready to respond to any additional concerns that the European Union or any other interested 
country may wish t o raise. Colombia is more than willing to continue the work that is being carried 
out and to address this concern.  
2.1.4.61   Brazil - MAPA Ordinance No. 208, 26 February 2021 – revision of the Decree No. 
6.87 of 4 June 2009 on the standardisation, classification, re gistration, inspection, 
production and supervision of alcoholic beverages, G/TBT/N/BRA/1145  (ID 712104) 
2.458.   The representative of the European Union  provided the following statement.  The European 
Union would like to thank Brazil for submitting notifications G/TBT/BRA/1145/Add.1  and 
G/SPS/N/BRA/2033  published on 19 and 20 A pril 2022 and for the opportunity to comment on the 
draft texts. The European Union provided written comments to this notification on 13 July 2022 and 
would be grateful if it could receive a reply to them. In particular, the European Union would like to 
know whether imported beverages will fall under the registration requirement or whether they will 
benefit from a possible exemption. Furthermore, the European Union suggested removing the 
requirement to include the expressions "alcoholic strength" or "alcoho l content " as envisaged by the 
notified draft given that the international practice of using terms such as "alcohol ", "alc" is sufficiently 
clear and does not mislead consumers. The proposed changes would cause producers to incur costs 
 
103 For previous statements follow the thread under ID 697 . 
104 For previous statements follow the thread under ID 712 . G/TBT/M/88  
 
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  to replace all labels and those costs do not appear to be justified and could give rise to an 
unnecessary obstacle to trade.  
2.459.   The European Union notes that the "bebidas alcoólicas" (alcoholic beverages) category sets 
an upper limit of not more than 54% of alcoholic streng th by volume. The EU would like to ask Brazil 
to provide justification for setting a maximum limit on the alcohol content of spirits, which may not 
be in line with international standards. The EU therefore asks the Brazilian authorities to consider 
not app lying the maximum limit of 54.0 % ABV to spirit drinks imported in Brazil, as this limit might 
create an obstacle to international trade. The European Union asks that Brazil remove the maximum 
alcohol content in all corresponding articles on spirits, in li ne with international practice. The 
European Union also asked for a number of clarifications concerning spirits categories definitions in 
notified draft such as liqueur, rum, whiskey, vodka, gin and aquavit, which may not be in line with 
international prac tice and may cause unnecessary obstacles to trade. In this respect, the EU would 
like to recall Article 2.2 of the TBT Agreement according to which "Members shall ensure that 
technical regulations are not prepared, adopted or applied with a view to or with  the effect of creating 
unnecessary obstacles to international trade. For this purpose, technical regulations shall not be 
more trade restrictive than necessary to fulfil a legitimate objective, taking account of the risks non -
fulfilment would create ". The European Union would be grateful if the above -mentioned comments 
could be taken into account and replied to before adoption of the notified draft.  
2.460.   In response, the representative of Brazil  provided the following statement. Brazil would like 
to thank the E U for its statement and for the comments it submitted in reply to notification 
G/TBT/N/BRA/1145/Add.1 . We also welcome the contributions from other countries to our public 
consultation. Brazilian authorities are currently reviewing all of them and we would like to ass ure 
that they will be duly considered. In the next steps of this regulatory process, we will publish our 
answers to the comments and also a revised draft regulation of law No. 8,918, of 14 July 1994 
(Beverage Law). This revised draft will be notified to al l Members, and further comments will be 
accepted. We appreciate engagement from our trade partners and assure them that the 
development of this regulation will remain transparent and aligned to our WTO commitments.  
2.2  Exchange of Experiences  
2.2.1   Transparency  
2.2.1.1   Upda te on the Transparency Working Group  
2.461.   The Chair recalled that the meeting s of the Transparency Working Group were open to all 
delegations and were held in hybrid mode. Its first meeting had been held on 6 April 2022 and a 
second meeting was held on 13  Octob er 2022. During its second meeting , in October , the Working 
Group had discussed two proposals.  
2.462.   The first proposal from the United States  is contained in document JOB/TBT/466 ; it suggest s 
a possible revision of the regular notification format to better track certain measures being notified, 
sometimes with a comment period, which would normally fall under the coverage of Article 15.2.  
During the meeting the US had provided a recap of the proposal and s hared a mock -up of a revised 
regular notification format with an additional tick box under item 3. The US  had highlighted that the 
proposal would not alter Member obligations but would facilitate tracking of changes to overarching 
policies such as those re lated to quality infrastructure.  Members shared their comments and 
questions regarding the proposal including South Africa which submitted its comments in writing in 
the document JOB/TBT/480 . Issues raised revolved around the importance of maintaining the 
balance of rights and obligations under the Agreement.  
2.463.   The second proposal , from Canada , contained in JOB/TBT/485  focused on a revision of the 
notification guidelines with the aim of facilitating a better understanding of notified measures , in 
particular those drafted in languages other than English, French and Spanish. Following Canada's 
presentation , Members shared questions and comments with respect to naming authorities 
responsible for undertaking conformity assessment, adding links to international standards,  and 
providing indicative timelines when no date has been set for adopting or entry into force of the 
notified measure. With respect to the other triennial review recommendations on transparency, the 
US had volunteered to work with the Secretariat in devel oping a new format for submitting 
Article 15.2 notifications through ePing.  G/TBT/M/88  
 
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  2.464.   The Chair noted that  delegations could consult the Secretariat's presentation , contained in 
document JOB/TBT/487 , which provided an overview of practices and recommendations related to 
Article 15.2.  
2.465.   The represent ative of Canada  thanked Members that intervened at the working group 
meeting with their views and comments on the proposal. He stated that based on the questions and 
inputs received at the October working group meeting Canada would revise the proposal .  
2.466.   The representative of the United Kingdom  stated that the UK supported both proposals and 
believe d that they would facilitate an improved clarity of the notification process.  
2.467.   The representative of Australia  noted  that Australia was supportive of this proposa l to 
improve provisions in the Agreement.  
2.468.   The representative of China  thanked the US and Canada for their proposals. He noted that 
regarding the proposal from the US, China had comments but would like to continue the discussion 
within the context of the t ransparency working group.  
2.469.   The representative of South Africa  noted that his delegation was committed to the work  on 
transparency and expressed an interest to  work with the US on developing a template for Article 
15.2 statements.   
2.2.1.2   Statement from Members on Article 15.2  
2.470.   The Chair recalled that Article 15.2 requires Members to provide information on measures 
put in place to ensure the implementation of the Agreement and to notify any changes over time. 
The Chair reminded delegations that Article 15. 2 notifications are accessible through the ePing 
platform. It was also noted that Egypt had recently submitted a revision of its earlier statement of 
implementation. This update can be found in the document G/TBT/2/Add.34/Rev.3 .  
2.2.1.3   Secretariat update on the ePing SPS&TBT Platform  
2.471.   The Chair recalled that the new version of the ePing platform had been officially launched 
on Wednesday 13 July, with the participation of senior representatives from the three partner 
organizations: ITC, UND ESA and WTO. An official record of the launch had been  issued by the 
Secretariat  in document G/TBT/GEN/336 , including statements from the three organizations as well 
as comments from Members. Additionally, an ePing information session had been held on 
14 November  2022.  
2.472.   The Secretariat  recalled that during the two -hour information session, the Secretariat 
demonstrated the key functions of ePing and heard from five Members about the various ways they 
have incorporated ePing into their workflows. At the session t he Philippines discussed a  national 
awareness raising seminar where one business pointed out how ePing helps them manage risks and 
improve supply chain planning. Another example was from Vietnam where the foreign trade 
university includes ePing in its trade policy courses and trans lates selected notifications into 
Vietnamese for the benefit of MSMEs. At the session , Kenya also shared their experience on how 
they are building on ePing training conducted during the transparency champions program to 
improve coordination when submitting  notifications and increase engagement with national and 
international stakeholders. The United States also shared their experience regarding how they are 
transitioning their stakeholders from the Notify US alert system to ePing and how they use ePing's 
international forum chat functions to communicate with counterparts and other Members. Lastly, 
Ecuador shared how they utilise ePing to coordinate the preparation of their notifications and 
communicate with other enquiry point officials. The main challenges raised at the session related to 
identification of HS codes corresponding to regulated products, access to translation s and receiving 
substantive feedback from the private sector.  
2.473.   The Secretariat also noted that a virtual information session was planned f or 29 November 
targeting officials who have notification administrator rights on ePing,  and an announcement would 
be sent out for this session. Further, it was noted that for the year ahead there would be dedicated 
sessions focusing on ePing's communicatio n functions such as the national and international fora G/TBT/M/88  
 
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  and the chat function. It was reminded that the ePing app was available for smartphones, both Apple 
and Android.  
2.474.   The representative of the United States  expressed their appreciation and support for ePing 
and stated that both Members and stakeholders alike ha d benefited from it. She also recognized 
that there would be a need for  additional resources , such as training materials  for stakeholders to 
benefit from ePing and ot her electronic tools.   
2.475.   The representative of Chile echoed the statement of the United States regarding ePing.  
2.2.2   Tenth Special Meeting on Procedures for Information Exchange  
2.476.   The Chair recalled that the TBT Committee had agreed , in 1995 , to hold regular meeti ngs 
for persons responsible for information exchange, including those responsible for enquiry points and 
notifications. The 9th Special Meeting on Procedures for Information Exchange was held on 18 -
19 June 2019 and its meeting report can be found in G/TBT/GEN /265. The Chair proposed th at the 
10th Special Meeting be held on 19 June 2023 . It was so agreed .  
2.2.3   Conformity Assessment Procedures  
2.477.   The Chair recalled that in the Eighth Triennial Review of the TBT Agreement, the Committee 
had agreed to develop guidelines to support regulators in the choice and design of conformity 
assessment procedures. Subsequently, in the Ninth Triennial Review, the Committe e noted progress 
to date and agreed to finalize this work. The Secretariat circulated a revised elements paper for the 
CAP guidelines in the document JOB/TBT/438/Rev.1 . Additionally, fo llowing the 29 June meeting , 
the Secretariat  circulated an Aide -Memoire on the revised elemen ts paper contained in the document 
JOB/TBT/484  issued on 14 September.  An informal meeting was held on 13 October to further 
discuss work on the guidelines  as well as other consultations with Members.  The Chair noted that 
the consultations were open to all interested Members and that specific dates would be 
communicated at a later stage.  
2.2.4   Regulatory Cooperation between Members  
2.2.4.1   Report by the Moderator on the Thematic Session on Good Regulatory Practices  
2.478.   The Moderator105 for the thematic session on Good Regulatory Practices, held on 
15 November 2022 and covering domestic implementation of GRP and GRP in trade agreements , 
provided his report. The full report is contained in  G/TBT/GEN/338 .   
2.2.4.2   Report by the Moderator on the Thematic Session on Standards D evelopment in 
Codex  
2.479.   The Moderator106 for the thematic session on Standards Development in Codex, held on 
15 November 2022 and covering the present work of the Codex Alimentarius commission on 
standards, recent work in the Codex committee on Food Labelling (CCFL) and exchange of 
experiences from Member s on challenges and opportunities in standards -setting activities of Codex 
Alimentarius,  provided her report. The full report is contained in G/TBT/GEN/339 .  
2.2.5   Covid -19 
2.2.5.1   Update s from Secretariat  
2.480.   The Chair  recalled the TBT Committee's mandate on COVID -19107, and that the Chairperson 
had asked the Secretariat to prepare a background document on the work of the Committee to date 
since the start of the pandemic. The Secretariat presented this background document at the July 
 
105 Mr. Don Spedding (Australia).  
106 Ms. Lorena Rivera (Colombia).  
107 G/TBT/46 , para. 8.4.  G/TBT/M/88  
 
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  meeting which was then circulated in JOB/TBT/458 . The Chair also noted th at on 31 October the 
Secretariat published a COVID -19 information note based on the background document.    
2.481.   The Chair also noted that the Chairperson of the CTG requested that the Chairs of all CTG 
subsidiary bodies prepare a report on the WTO response to C OVID -19 pandemic and preparedness 
for future pandemics, in light of the MC12 ministerial declaration. The report described activities of 
the TBT Committee in the context of the pandemic over the past two years a imed at a better 
understanding of how the Committee adjusted the focus of its work to address pandemic related 
issues. In light of this the Secretariat circulated a draft of this report to all Members for comments 
contained in JOB/TBT/490 .  
2.482.   The representative of the United States  said that her delegations wished to convey a few 
minor  comments to the Secretariat but overall thought it was a good report.  
2.2.6   Other Matters  
2.483.   On WTO reform t he Chair noted that the Chairperson of the CTG had also requested for 
Chairs of all CTG subsidiary bodies to prepare reports under their own responsibility on the 
functioning of their respective committees . In light of this request the Secretariat circulated a 
draft of the Chair's report, contained in document JOB/TBT/491 , that described the concrete actions 
taken by the TBT Committee over the past years to improve its work.  
2.484.   The representative of Brazil  thanked the Chair for the report and flagged that in the next 
steps of this stocktaking exercis e, the Committee would have a lot to contribute to reform 
discussions. He stated that the TBT Committee is one of the best examples of good practice in the 
WTO and should contribute more to reform discussions and the improvement of the deliberative 
functio ns of the WTO.  
2.485.   The representative of the United States  expressed that it was a source of pride that the TBT 
Committee ha d lots of good practices that other committees could emulate. She also raised a 
question on the deadline for delegations to provide com ments.  
2.486.   The representative of the European Union  echoed the previous comments by the delegations 
of Brazil and the US. She stated that this exercise was a good opportunity to highlight the 
cooperation among Members within the Committee.  
2.487.   The Chair announced  that the Secretariat had issued a revision of the compilation of 
decisions and recommendations  adopted by the TBT Committee since 1 January 1995 and can 
be found in the document G/TBT/1/Rev.15 . This latest revision incorporates the decisions and 
recommendations of the Committee from  the 9th Triennial Review concluded at the end of 2021. It 
also reflects other Committee developments since the issuance of the last version in September 
2019, for instance, the revised guidelines on the coherent use of notification formats of the new 
ePing SPS&TBT platform which has replaced a series of online tools.  
2.488.   On thematic sessions  the Chair stated that the topics for the March 2023 thematic sessions 
would be plastic regulation and climate change. He suggested to begin planning for the sessions 
with concrete inputs from delegations.  
2.489.   The representative of Canada  stated that Canada had  suggested for the Committee to hold 
a thematic session to share information, best practices and innovative ideas related to technical 
regulations, standards and conformity assessment procedures that support the attainment of 
environmental goals and contri bute to reducing climate change  thereby contributing to achieve 
goals of the Paris agreement while being as least trade restrictive as possible. He stated that Canada 
was pleased the Committee agreed to hold this session and had already begun to reflect on  potential 
speakers and topics. They also welcomed the interest of other Members who wished to be involved 
in any preparatory work leading to the March session or who may have suggestions on topics and 
speakers.  
2.490.   The representative of the United States  stated that as the proponent for the thematic session 
on plastic regulation, the US was looking forward to working alongside Canada and would help the 
Secretariat in reaching out to Members on potential topics and speakers for the session.  G/TBT/M/88  
 
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  2.491.   The representative  of the European Union  said that her delegation was paying greater 
attention to issues pertaining to climate change and would be happy to cooperate with Canada and 
the US on proposing speakers and topics  
2.492.   The representative of the United Kingdom  said the se ssion was of interest and that they 
looked forward to working with other Members.  
2.493.   The Chair recalled that in the 9th triennial review the Committee agreed to hold a thematic 
session in June 2023 on regulatory cooperation between Members with three separate  topics to be 
covered: digital products, cybersecurity, and a third topic yet to be defined . The Chair also 
recalled that Members agreed to hold a thematic session on current challenges and best practices 
for addressing issues related to conformity assessm ent of goods obtained through e -commerce. It 
had been agreed that the session would consider , inter alia , how Members can work to enhance the 
safety of products purchased online to protect consumer health and safety. The Chair proposed that 
this should be the third topic in the June thematic session, eliminating the need to assign a future 
date to hold this session while also being in alignment with the other two topics.   
2.494.   The representative of the United States  stated that as the two topics already propose d were 
cutting edge topics for the Committee, they anticipated that there would be a lot of interest from 
the Committee as well as other sections of the WTO, for instance, those focused on services. She 
asked for greater clarity first on how these discussi ons would fit into the June schedule before 
agreeing to another topic to discuss.  She also mentioned that sectoral based discussions bring a lot 
of life to the Committee thus needing to ensure that the two topics have adequate time to be 
discussed.  
2.495.   The Chair stated that he would get back to Members at the upcoming informal meeting on 
how the sessions would fit into the schedule and what options or alternatives there would be. The 
Chair also brought to attention that from the 9th triennial review, Members agreed to hold thematic 
sessions in November 2023 on regulatory cooperation between Members and an as yet 
undefined second topic . At the 9th triennial review Members agreed to hold a session key role of 
national quality infrastructure on Members' regulator y systems and implementing the TBT 
Agreement as well as another session on how Members incorporate international standards in 
regulatory processes with respect to conformity assessment. The Chair also noted that a thematic 
session on technical assistance h ad not yet been held during the triennial review cycle. He stated 
that past thematic sessions on technical assistance had proved useful and so would be another topic 
to consider.  
2.496.   The representative of Paraguay  flagged that from the options provided their preference was 
for the topic on how Members incorporate international standards into their regulatory processes for 
the November 2023 thematic session.   
2.497.   The Chair sought the view of delegations regarding webcasting of thematic sessions . He 
noted that as the sessions cover topics of interest to a broad range of stakeholders, delegations may 
wish to make these more accessible to domestic constituents and the general public. The link could 
be made available to delegations in advance so it could be forwarded to interested domestic 
constituents and following the conclusion of the session, the recording would be made available 
publicly through the WTO TBT gateway. He also noted that the SPS Committee would webcast all its 
thematic sessions goi ng forward.  
2.498.   The representative of the United States  expressed their support for webcasting the thematic 
sessions , however noted that for sessions that were more government focused they would prefer 
for closed sessions, calling back to the proposal for a t hematic session on how Members incorporate 
international standards into regulatory processes as an example of a more sensitive topic. She stated 
however that the March sessions for example were well suited to being webcast.  
2.499.   The representative of the Europ ean Union  echoed the previous sentiments and stated that 
it would be beneficial to webcast sessions to have a greater reach outside of the Committee while 
also being mindful of topics that may have particular sensitivities.  
2.500.   The representative of Kenya  expressed their support to webcast the thematic sessions.  G/TBT/M/88  
 
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  2.501.   The representative of Mexico  stated that they were largely in favour of webcasting the 
sessions and suggested that the sessions could also be recorded and then transmitted, or access 
granted at the end  of the meeting. She stated that this option of having the recording accessible 
after the meeting could also be suitable to sessions covering sensitive topics.  
2.502.   The representative of the United Kingdom  expressed their support to webcast the sessions 
and ec hoed Mexico's statement that releasing the recordings after the meeting would enable to 
determine on a case -by-case basis which sessions are publici zed.  
2.503.   The Chair  suggested that, henceforth , the thematic sessions would be webcast unless there 
were objecti ons going forward . If necessary, there would be consultations before meetings with 
regard to sensitive topics and if they should be webcast  or not. It was so agreed .  
2.504.   The representative of Türkiye  updated the Committee on their side event held on 
17 November that hosted the Standards and Metrology Institute for Islamic Countries ( SMIIC) and 
the Turkish Halal Accreditation Agency. The SM IIC which had a pending application to be an Observer 
to the TBT Committee informed participants on its functioning and global role in halal conformity 
assessment and accreditation. The SM IIC also presented its reasons for why it would like to be an 
Observer to the Committee and the ways they comply w ith requirements to become an Observer. 
This was followed by a presentation from the Turkish Halal Accreditation Agency informing 
participants about their activities and shared their views on opportunities for international 
cooperation in halal certified t rade, emphasizing the role of trust. The Turkish representative thanked 
Members for their interest in this event and their valued participation and reminded the membership 
that these presentations would be shared in a forthcoming room document to be circul ated by the 
Secretariat the following week. She concluded by thanking the Secretariat for their support in 
organizing the side event.108 
2.505.   The representative of Ukraine  provided an update of their TBT activities. She first expressed 
her delegations' gratitu de for the fruitful work of the TBT Committee and thanked Members for their 
unwavering support and leadership during these difficult times. She stated that Ukraine was doing 
its best to mitigate consequences to civilians and its eco nomy in light of sustained attacks by Russia 
to its energy grid. She stated that t he power outage s continue d to undermine economic activity and 
recovery  and that u nder the current conditions the work of relevant bodies in the field of technical 
regulations , standardization and metrology face d significant losses. However, Ukraine was taking 
steps to ensure stea dy work in these fields and ensure pr oper functioning of the technical regulatory 
system. She asserted that even in this difficult period Ukraine remain ed committed to transparency 
norms and continue d to notify Members on its legislation s.  
2.506.   Since the beginning of 2022 Ukraine ha d submitted 42 notifications  and replied to 35 
Members requests related to TBT issues. Ukraine ha d also designated 76 conformity assessment 
bodies and 2 recognized independent organizations to ensure conformity assessment procedures 
with requirements of technical regulations. Currently, 74 of the 76 designated bodies and the  two 
recognized independent organizations located in different regions of Ukraine continue d to perform 
full conformity assessment procedures in their permanent locations  however t he activity of  the other 
two had been  suspended due to security reasons. In some regions, the scientific and production 
centres for standardization , metrology and certification ha d been seriously  affected , such as in 
Kherson, Lugansk,  and Donetsk  where they had also been  forced to stop activities.  
2.507.   She recalled that the WTO was established to promote peaceful cooperation between 
governments on a variety of trade issues and the acts of aggression of the Russian Federation 
towards Ukraine ha d ruined the security framework that countries ha d been building over the past 
70 years ; this  and neglect ed the basic principles of the multilateral trading system. She concluded 
by reiterat ing Ukraine's gratitude to WTO Members for their overwhelming suppo rt and strong 
solidarity against Russia's brutal aggression .  
3  TECHNICAL COOPERATION ACTIVITIES  
3.1.  The representative of Chile inform ed the Committee that they would be organizing  a technical 
assistance activit y in Santiago  in April 2023 , in coordination with the Secretariat.  This would be to 
 
108 A room document containing information on the Türkiye's presentation is contained in RD/TBT/374 . G/TBT/M/88  
 
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  train interested parties  and regulatory bodies  on ePing . He stated that this would be of enormous 
value,  and they would continue to coordinate to ensure its success.  
3.2.  The Secretariat  provided an update on the Transparency Champions programme . The first 
pilot round of the programme began in October  with a one-week course in Geneva, in tandem with 
a similar pro gramme for SPS officials. The course would continue for the following six months  with 
some virtual sessions. The first cohort of Champions included 26 officials from African countries with 
responsibilities for TBT transparency procedures. The Secretariat t hanked Australia, Sweden , 
Uganda and the United States for supporting the  participation of their enquiry points and delegates 
as mentors in this programme and ARSO for providing a regional perspective.  
3.3.  The representative of the United States  drew attention to a n update on US technical assistance  
activities subsequently circulated in G/TBT/GEN/337 .  
3.4.  The representative of Namibia  thanked the Secretariat for the opportunity to share their 
participation experience in the Transparency Champions programme. She stated that often 
devel oping countries face challenges of stakeholder coordination in fulfilling transparency provisions 
and Namibia shared the same challenge. She stated that through her nomination into the program 
her outlook had changed on the subject of transparency. Notably , she learned about tools such as 
ePing which enhance transparency by improving coordination between national notification 
authorities , national enquiry points, regulatory authorities,  and the public and private sector. She 
stated that these lessons were relevant to Namibia as they aim to strengthen their national TBT 
coordination and enable the submission , dissemination, and facilitation for domestic and 
international notifications and comments. This would help facilitat e with getting inputs  from p ublic 
and private sectors on their specific trade concerns. She stated that Namibia's  National Standards 
Institute  (NSI) successfully implemented various initiatives after the programme such as stakeholder 
engagement with  regula tors and businesses, training workshops on ePing and the use of good 
regulatory practices.  
3.5.  The national initiative resulted in an increased number of ePing users which enabled them to 
create a national forum on ePing. She stated that the programme was an exciting period  to meet 
TBT officials from the same region and  have the opportunity to share experiences and challenges. 
They learned that setting up a national  functional  structure to operationali ze TBT offices remain s a 
challenge for regional counterparts.   
3.6.  The representative of Namibia also expressed appreciation for the mentors from the Enquiry 
Points of Australia, Sweden, Uganda,  and the United States and reiterated that continuous capacity 
building support remains imperative to enable impro ved TBT transparency . They concluded by saying 
they looked forward to the implementation and accomplishment of activities as outlined in their 
action plans.  
3.7.  The representative of South Africa  thanked the Secretariat for the opportunity to participate in 
the Transparency Champions programme. He stated that the programme was comprehensive and 
provided them with content, materials, lessons,  and experience relevant to their daily work across 
the TBT value chain from the e nquiry points , national TBT domestic coordination to the policy 
development level. The programme helped them develop a deeper understanding  of the TBT 
Agreement, in particular the transparency provisions  and learning more about digital tools such as 
ePing . He stated that a unique element of the programme was in how participants could implement 
what they learnt through actionable ideas in their respective countries.   
3.8.  The representative of Uruguay  thanked the Secretariat for the successful technical assistance 
activity on TBT that took place earlier in the year (August 2022) and had greatly helped to improve 
their situation with respect to the implementation of the TBT Agreement in his country.   
4  OBSERVERS  
4.1  Updates from Observers  
4.1.  Updates were provided by ISO (G/TBT/GEN/340) , Codex  (G/TBT/GEN/341) , BIPM 
(G/TBT/GEN/342 ), ARSO (G/TBT/GEN/343 ) and OIML (G/TBT/GEN/344) .   G/TBT/M/88  
 
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  4.2.  The representative of OIML pointed out to Members that , in their written report , there was a 
section concerning electric vehicle supply equipment and expressed their concern that regulators in 
various parts of the world are starting to develop metrology regulations for charging equipment for 
these vehicles for  which requirements are not always mutually compatible. The OIML started a 
project in October the previous year to develop a model technical regulation for this with a guide 
already available on their website.  
5  ANNUAL REPORT (2022) OF THE COMMITTEE TO THE COUNCIL FOR TRADE IN GOODS  
5.1.  The Chair  noted that the Committee submitted a draft of its  Annual Report to the Council for 
Trade in Goods contained in JOB/TBT/486  and was circulated on 13  October  2022. The report was 
subsequently adopted and circulated in G/L/1445 . 
6  DATE OF NEXT MEETING  
6.1.  The Chair recalled that the next meeting of the TBT Committee was scheduled to take place on 
from 8 to 10 March 2023. The regular meeting w ould be preceded by thematic sessions on 7 March 
on regulatory cooperation between Members focusing on the topics of plastic regulation and climate 
change.  
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